Macular EdemaPhase 3POINTNCT02374060
PeriOcular and INTravitreal Corticosteroids for Uveitic Macular Edema Trial
A Phase 3 study testing Periocular triamcinolone 40 mg, Intravitreal triamcinolone 4 mg and Dexamethasone intravitreal implant in people with Macular Edema and Uveitis, run by JHSPH Center for Clinical Trials at 26 sites in 4 countries.
Trial summary
To evaluate the relative efficacy of three commonly utilized regional corticosteroids for the regional treatment of uveitic macular edema: periocular triamcinolone acetonide; intravitreal triamcinolone acetonide; intravitreal dexamethasone implant. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Macular Edema, Uveitis
- What is being tested?
- Periocular triamcinolone 40 mg, Intravitreal triamcinolone 4 mg and Dexamethasone intravitreal implant
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 26 sitesin 4 countries
- Study dates
- 16 Jun 2015to 4 Jan 2018
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Eye level inclusion criteria - at least one eye must meet all of the following conditions:
- Non-infectious anterior, intermediate, posterior or panuveitis; either active or inactive uveitis is acceptable;
- Macular edema (ME) defined as the presence of central subfield macular thickness greater than the normal range for the OCT machine being used, regardless of the presence of cysts, as assessed by study ophthalmologist;
- Best corrected visual acuity (BCVA) 5/200 or better;
- Baseline intraocular pressure > 5 mm Hg and ≤ 21 mm Hg (current use of 3 or fewer intraocular pressure-lowering medications and/or prior glaucoma surgery are acceptable);
- Baseline fluorescein angiogram that is gradable for leakage in the central subfield
- Pupillary dilation sufficient to allow OCT testing.
Who cannot join
- Patient level exclusion criteria:
- -History of infectious uveitis, or of scleritis, keratitis, or infectious endophthalmitis in either eye;
- History of central serous retinopathy in either eye;
- For women of childbearing potential: pregnancy, breastfeeding, or a positive pregnancy test; unwilling to practice an adequate birth control method (abstinence, combination barrier and spermicide, or hormonal) for duration of trial;
- Use of oral acetazolamide or other systemic carbonic anhydrase inhibitor at baseline;
- Oral prednisone dose > 10 mg per day (or of an alternative corticosteroid at a dose higher than that equipotent to prednisone 10 mg per day) OR oral prednisone dose ≤ 10 mg per day that has not been stable for at least 4 weeks(note that if patient is off of oral prednisone at baseline (P01 visit), dose stability requirement for past 4 weeks does not apply);
Show all 17Show fewer
- Systemic immunosuppressive drug therapy that has not been stable for at least 4 weeks;
- Known allergy or hypersensitivity to any component of the study drugs;
- Eye level exclusion criteria - at least one eye that meets all inclusion criteria cannot have any of the following conditions:
- History of severe glaucoma as defined by optic nerve damage (cup/disc ratio of ≥ 0.9 or any notching of optic nerve to the rim);
- Media opacity causing inability to assess fundus or perform OCT;
- Presence of an epiretinal membrane noted clinically or by OCT that per the judgment of study ophthalmologist may be significant enough to limit improvement of ME (i.e., causing substantial wrinkling of the retinal surface)81;
- Torn or ruptured posterior lens capsule;
- Presence of silicone oil;
- Periocular or intravitreal corticosteroid injection in past 8 weeks;
- Injection of dexamethasone intravitreal implant in past 12 weeks;
- Placement of fluocinolone acetonide implant (Retisert) in past 3 years;
Trial locations and contacts
26 sites in 4 countries.
26 sites in 4 countries
United States23 sites
Kellogg Eye Center, University of Michigan
Ann Arbor, Michigan, 48105
Emory University
Atlanta, Georgia, 30322
Johns Hopkins University
Baltimore, Maryland, 21287
National Eye Institute, NIH
Bethesda, Maryland, 20892
Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, 02114
Ophthalmic Consultants of Boston
Boston, Massachusetts, 02114
Northwestern University
Chicago, Illinois, 60611
Rush University Medical Center
Chicago, Illinois, 60612
Duke Eye Center, Duke University
Durham, North Carolina, 27710
Vitreoretinal Consultants
Houston, Texas, 77030
University of Iowa
Iowa City, Iowa, 52242
Jules Stein Eye Institute, UCLA
Los Angeles, California, 90095
Anne Bates Leach Eye Hospital, University of Miami Miller School of Medicine
Miami, Florida, 33136
New York Eye and Ear Infirmary
New York, New York, 10016
Scheie Eye Institute, University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Wills Eye Hospital
Philadelphia, Pennsylvania, 19107
Unniversity of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
MAYO Clinic
Rochester, Minnesota, 55905
John A. Moran Eye Center, University of Utah
Salt Lake City, Utah, 84132
University of California, San Francisco
San Francisco, California, 94143
University of Washington
Seattle, Washington, 98104
Washington University School of Medicine
St Louis, Missouri, 63110
University of South Florida
Tampa, Florida, 33612
About this study
To evaluate the relative efficacy of three commonly utilized regional corticosteroids for the regional treatment of uveitic macular edema: periocular triamcinolone acetonide; intravitreal triamcinolone acetonide; intravitreal dexamethasone implant. The primary efficacy measure will be percent change in central subfield thickness as measured by OCT at 8 weeks. Participants will continue in the study for 24 weeks in order to evaluate relative effects of the 3 treatment strategies on the duration of treatment effects, requirement for additional injections, and adverse effects.
Note: The planned sample size for the POINT Trial was 267 subjects. On 17 July 2017, with 192 subjects enrolled, the Data and Safety Monitoring Committee (DSMC) reviewed the planned interim analysis and recommended that the goals of the trial could be accomplished by completing follow-up of enrolled subjects without the recruitment of additional subjects. Per the DSMC recommendations, recruitment was suspended and follow-up of enrolled subjects was completed according to the protocol.
Read the detailed description
Macular edema is the most common structural complication and leading cause of visual loss in patients with uveitis. Regional injections of corticosteroids are the most frequently used treatments specifically for uveitic macular edema but there is a lack of high quality evidence to guide choice of drug (e.g., triamcinolone acetonide, dexamethasone) and route of administration (e.g. periocular, intravitreal). The question of how to approach regional treatment of uveitic macular edema is a key question for ophthalmologists treating these patients. The Periocular and Intravitreal Corticosteroids for Uveitic Macular Edema (POINT) Trial is a randomized trial designed to compare the relative efficacy of three regional corticosteroids commonly utilized for the initial regional treatment of uveitic macular edema, periocular triamcinolone (Kenalog® , Bristol-Myers Squibb Company, Princeton, NJ), intravitreal triamcinolone (Triesence™, Alcon Pharmaceuticals, Fort Worth, TX), and the intravitreal dexamethasone implant (Ozurdex®, Allergan, Irvine CA) will be conducted by the MUST Research Group clinical centers throughout the U.S. and one each in Australia and the UK. After signing informed consent and undergoing eligibility evaluation, eligible patients will be randomized to one of the three study treatments to be administered at the first study visit. Randomization is by participant, if both eyes meet eligibility requirements then both eyes receive assigned treatment. The design outcome is the percent change in central subfield macular thickness on OCT from baseline to the 8 week visit. After assessment of the primary outcome at 8 weeks, second injections and best medical judgment will be used if macular edema has not improved as follows:
Eye(s) meeting trial eligibility criteria receive initial injection of assigned treatment at P01 visit.
Second injection of assigned treatment permitted at 8 week visit for periocular triamcinolone and intravitreal triamcinolone and at 12 week visit for intravitreal dexamethasone if
- Eye does not meet the improvement definition (a 20% decrease in central subfield thickness of the macula) or
- Eye has a normal central subfield thickness but has cystoid spaces in the 1 mm central subfield or
- ME is worse after initial improvement
And the following repeat injection criterion are met:
- IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents;
Eyes demonstrating no improvement or worsening of ME as measured by the central submacular thickness on OCT (at week 12 for periocular and intravitreal triamcinolone arms and at week 20 for intravitreal dexamethasone arm) are considered primary treatment non-responders.
- Conditions
- Macular Edema, Uveitis
- Being tested
- Periocular triamcinolone 40 mg, Intravitreal triamcinolone 4 mg, Dexamethasone intravitreal implant
- Medical subject headings
- Macular Edema, Uveitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Periocular triamcinolone 40 mgDrug
Also called Kenalog
Periocular triamcinolone acetonide, 40 mg injection may be given either by posterior sub-Tenon's approach or by the orbital floor approach, as both appear to have similar efficacy; the approach to the periocular injection will be recorded for analysis if needed.
Intravitreal triamcinolone 4 mgDrug
Also called Triescence (in U.S); Kenalog allowed at non-U.S. clinics
Intravitreal triamcinolone acetonide, 4 mg injection procedures should be carried out under controlled aseptic conditions which include the use of sterile gloves and a sterile eyelid speculum (or equivalent). Adequate anesthesia and a broad-spectrum microbicide such as betadine, applied to the periocular skin, eyelid and ocular surface are required prior to an intravitreal injection.
Dexamethasone intravitreal implantDrug
Also called Ozurdex
- Standard preparation as described for intravitreal injections.
| Study group | Role | What they receive |
|---|---|---|
| Periocular triamcinolone 40mg | Active comparator | Periocular triamcinolone acetonide (Kenalog), 40 mg Initial injection at Week 0
Second injection permitted at Week 8 IF:
* Eye does not meet the improvement definition (a 20% decrease in central subfield thickness of the macula) OR eye has a normal central subfield thickness but has cystoid spaces in the 1 mm central subfield OR ME is worse after initial improvement;
* IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents; Receives: Drug: Periocular triamcinolone 40 mg |
| Intravitreal triamcinolone 4mg | Active comparator | (preservative-free preparation, Triescence at U.S. clinics; Triesence preferred at non-U.S. clinics but Kenalog allowed) (4 mg) Initial injection at Week 0
Second injection permitted at Week 8 IF:
* Eye does not meet the improvement definition (a 20% decrease in central subfield thickness of the macula) OR eye has a normal central subfield thickness but has cystoid spaces in the 1 mm central subfield OR ME is worse after initial improvement;
* IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents; Receives: Drug: Intravitreal triamcinolone 4 mg |
| Dexamethasoneintravitreal implant | Active comparator | Dexamethasone intravitreal implant (Ozurdex) (0.7 mg) Initial injection at Week 0
Second injection permitted at Week 12 IF:
* Eye does not meet the improvement definition (a 20% decrease in central subfield thickness of the macula) OR eye has a normal central subfield thickness but has cystoid spaces in the 1 mm central subfield OR ME is worse after initial improvement;
* IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents; Receives: Drug: Dexamethasone intravitreal implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Baseline Central Subfield Thickness Observed at 8 Weeks
The primary outcome is the change in central subfield thickness from baseline to 8 weeks measured on a relative scale as the the proportion of the baseline central subfield thickness. Values less than 1 indicate a decrease in retinal thickness with lower values indicating greater decreases. Smaller values are better.
The time point of 8 weeks was chosen for assessment of the primary outcome because it encompasses the window for maximum benefit for all three treatment strategies. Retinal thickness was evaluated using masked assessments of OCT images.
Measured: At baseline and 8 weeks
Secondary outcomes (14)
Proportion of Baseline Central Subfield Thickness Observed at 24 Weeks
The primary outcome is the change in central subfield thickness from baseline to 24 weeks measured on a relative scale as the the proportion of the baseline central subfield thickness. Values less than 1 indicate a decrease in retinal thickness with lower values indicating greater decreases. Smaller values are better.The time point of 24 weeks was chosen to evaluate the duration of response and the need for additional injections.Retinal thickness was evaluated using masked assessments of OCT images.
Measured: At baseline and the 24 week visit
Proportion of Eyes With >= 20% Reduction in Macular Thickness (or Normalization Even if <20% Reduction) at 8 Weeks
Proportion of eyes with >=20% reduction in macular thickness (or normalization of macular thickness even if there is <20% reduction) at 8 weeks.
Measured: Over 8 weeks of follow-up
Proportion of Eyes With >= 20% Reduction in Macular Thickness (or Normalization Even if <20% Reduction) at 24 Weeks
Proportion of eyes with >=20% reduction in macular thickness (or normalization of macular thickness even if there is <20% reduction) at 24 weeks
Measured: Over 24 weeks of follow-up
Proportion of Eyes With Resolution of Macular Edema at 8 Weeks
Proportion of eyes with resolution of macular edema defined as normalization of the macular thickness (i.e., < 260 um on the standardized scale) at 8 weeks. The greater the proportion the more eyes achieved resolution of macular edema.
Measured: Over 8 weeks of follow-up
Proportion of Eyes With Resolution of Macular Edema at 24 Weeks
Proportion of eyes with resolution of macular edema defined as normalization of the macular thickness (i.e., <260 um on the standard scale) at 24 weeks.
Measured: Over 24 weeks of follow-up
Change in Best-corrected Visual Acuity at 8 Weeks
Mean change in best-corrected visual acuity from baseline to 8 weeks. Participants' visual acuity was measured by certified examiners with best refractive correction in place.Participants were challenged with reading letters on lines of the standard ETDRS eye chart (5 letters per line). Lines became smaller as participants progressed from the top to the bottom of the chart. Participants read down the chart until no more meaningful readings could be made and were scored by how many letters could be correctly identified. More letters read is associated with higher visual acuity.
Measured: Over 8 weeks of follow-up
Change in Best-corrected Visual Acuity at 24 Weeks
Mean change in best-corrected visual acuity from baseline to 24 weeks. Participants' visual acuity was measured by certified examiners with best refractive correction in place.Participants were challenged with reading letters on lines of the standard ETDRS eye chart (5 letters per line). Lines became smaller as participants progressed from the top to the bottom of the chart. Participants read down the chart until no more meaningful readings could be made and were scored by how many letters could be correctly identified. More letters read is associated with higher visual acuity.
Measured: Over 24 weeks of follow-up
Number of Eyes With Vitreous Hemorrhage
Count of eyes with vitreous hemorrhage as an immediate complication of injection.
Measured: During 24 weeks of follow-up
Number of Eyes With Retinal Tear or Detachment
Count of eyes with retinal tears or detachments during the course of follow-up.
Measured: During 24 weeks of follow-up
Number of Eyes With Endophthalmitis
Count of eyes with an occurrence of endophthalmitis
Measured: During 24 weeks of folllow-ip
Cumulative Proportion of Eyes With Severe Vision Loss
Cumulative proportion of eyes with uveitic macular edema who experience severe vision loss (>= 15 standard letters) during the 24 weeks of follow-up.
Measured: During 24 weeks of follow-up
Cumulative Proportion of Eyes With an IOP Elevation of >=10 mm Hg Over Baseline
Cumulative proportion of eyes with uveitic macular edema that experience an IOP elevation of >=10 mm Hg higher than the baseline level during 24 weeks of follow-up.
Measured: During 24 weeks of follow-up
Cumulative Proportion of Eyes With an IOP Elevation >=24 mm Hg
Cumulative proportion of eyes with uveitic macular edema that experience elevated IOP to >=24 mm Hg during 24 weeks of follow-up.
Measured: During 24 weeks of follow-up
Cumulative Proportion of Eyes With an IOP Elevation >=30 mm Hg
Cumulative proportion of eyes with uveitic macular edema that experience elevated IOP to >=30 mm Hg during 24 weeks of follow-up.
Measured: During 24 weeks of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2015 (estimated)
- Study start16 Jun 2015
- Primary completion30 Aug 2017
- Study completion4 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Macular EdemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- JHSPH Center for Clinical Trials
- Sponsor type
- University, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Responsible party
- Sponsor
- Investigators
- Douglas A Jabs, MD, MBA, Study chair, Icahn School of Medicine, Noutn Sinai, New York, NY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02374060
- Sponsor's protocol ID
- IRB00006139
- Other IDs
- 1U10EY024527-01
- Acronym
- POINT
- Status last verified
- May 2018
- First submitted
- 18 Feb 2015
- Last updated
- 4 Dec 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Thorne JE, Sugar EA, Holbrook JT, Burke AE, Altaweel MM, Vitale AT, Acharya NR, Kempen JH, Jabs DA; Multicenter Uveitis Steroid Treatment Trial Research Group. Periocular Triamcinolone vs. Intravitreal Triamcinolone vs. Intravitreal Dexamethasone Implant for the Treatment of Uveitic Macular Edema: The PeriOcular vs. INTravitreal corticosteroids for uveitic macular edema (POINT) Trial. Ophthalmology. 2019 Feb;126(2):283-295. doi: 10.1016/j.ophtha.2018.08.021. Epub 2018 Sep 27.
PubMed 30269924
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PeriOcular and INTravitreal Corticosteroids for Uveitic Macular Edema Trial
- ClinicalTrials.gov ID
- NCT02374060
- Acronym / sponsor ID
- POINT / IRB00006139
- Conditions
- Macular Edema, Uveitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- JHSPH Center for Clinical TrialsUniversity, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Study start
- 16 Jun 2015 (actual)
- Primary completion
- 30 Aug 2017 (actual)
- Study completion
- 4 Jan 2018 (actual)
- First posted
- 27 Feb 2015 (estimated)
- Results
- Posted 5 Nov 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the relative efficacy of three commonly utilized regional corticosteroids for the regional treatment of uveitic macular edema: periocular triamcinolone acetonide; intravitreal triamcinolone acetonide; intravitreal dexamethasone implant. The primary efficacy measure will be percent change in central subfield thickness as measured by OCT at 8 weeks. Participants will continue in the study for 24 weeks in order to evaluate relative effects of the 3 treatment strategies on the duration of treatment effects, requirement for additional injections, and adverse effects.
Note: The planned sample size for the POINT Trial was 267 subjects. On 17 July 2017, with 192 subjects enrolled, the Data and Safety Monitoring Committee (DSMC) reviewed the planned interim analysis and recommended that the goals of the trial could be accomplished by completing follow-up of enrolled subjects without the recruitment of additional subjects. Per the DSMC recommendations, recruitment was suspended and follow-up of enrolled subjects was completed according to the protocol.
Detailed description
Macular edema is the most common structural complication and leading cause of visual loss in patients with uveitis. Regional injections of corticosteroids are the most frequently used treatments specifically for uveitic macular edema but there is a lack of high quality evidence to guide choice of drug (e.g., triamcinolone acetonide, dexamethasone) and route of administration (e.g. periocular, intravitreal). The question of how to approach regional treatment of uveitic macular edema is a key question for ophthalmologists treating these patients. The Periocular and Intravitreal Corticosteroids for Uveitic Macular Edema (POINT) Trial is a randomized trial designed to compare the relative efficacy of three regional corticosteroids commonly utilized for the initial regional treatment of uveitic macular edema, periocular triamcinolone (Kenalog® , Bristol-Myers Squibb Company, Princeton, NJ), intravitreal triamcinolone (Triesence™, Alcon Pharmaceuticals, Fort Worth, TX), and the intravitreal dexamethasone implant (Ozurdex®, Allergan, Irvine CA) will be conducted by the MUST Research Group clinical centers throughout the U.S. and one each in Australia and the UK. After signing informed consent and undergoing eligibility evaluation, eligible patients will be randomized to one of the three study treatments to be administered at the first study visit. Randomization is by participant, if both eyes meet eligibility requirements then both eyes receive assigned treatment. The design outcome is the percent change in central subfield macular thickness on OCT from baseline to the 8 week visit. After assessment of the primary outcome at 8 weeks, second injections and best medical judgment will be used if macular edema has not improved as follows:
Eye(s) meeting trial eligibility criteria receive initial injection of assigned treatment at P01 visit.
Second injection of assigned treatment permitted at 8 week visit for periocular triamcinolone and intravitreal triamcinolone and at 12 week visit for intravitreal dexamethasone if
- Eye does not meet the improvement definition (a 20% decrease in central subfield thickness of the macula) or
- Eye has a normal central subfield thickness but has cystoid spaces in the 1 mm central subfield or
- ME is worse after initial improvement
And the following repeat injection criterion are met:
- IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents;
Eyes demonstrating no improvement or worsening of ME as measured by the central submacular thickness on OCT (at week 12 for periocular and intravitreal triamcinolone arms and at week 20 for intravitreal dexamethasone arm) are considered primary treatment non-responders.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Periocular triamcinolone 40mg | Active comparator | Drug: Periocular triamcinolone 40 mgPeriocular triamcinolone acetonide (Kenalog), 40 mg Initial injection at Week 0 Second injection permitted at Week 8 IF: * Eye does not meet the improvement definition (a 20% decrease in central subfield thickness of the macula) OR eye has a normal central subfield thickness but has cystoid spaces in the 1 mm central subfield OR ME is worse after initial improvement; * IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents; |
| Intravitreal triamcinolone 4mg | Active comparator | Drug: Intravitreal triamcinolone 4 mg(preservative-free preparation, Triescence at U.S. clinics; Triesence preferred at non-U.S. clinics but Kenalog allowed) (4 mg) Initial injection at Week 0 Second injection permitted at Week 8 IF: * Eye does not meet the improvement definition (a 20% decrease in central subfield thickness of the macula) OR eye has a normal central subfield thickness but has cystoid spaces in the 1 mm central subfield OR ME is worse after initial improvement; * IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents; |
| Dexamethasoneintravitreal implant | Active comparator | Drug: Dexamethasone intravitreal implantDexamethasone intravitreal implant (Ozurdex) (0.7 mg) Initial injection at Week 0 Second injection permitted at Week 12 IF: * Eye does not meet the improvement definition (a 20% decrease in central subfield thickness of the macula) OR eye has a normal central subfield thickness but has cystoid spaces in the 1 mm central subfield OR ME is worse after initial improvement; * IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents; |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Eye level inclusion criteria - at least one eye must meet all of the following conditions:
- Non-infectious anterior, intermediate, posterior or panuveitis; either active or inactive uveitis is acceptable;
- Macular edema (ME) defined as the presence of central subfield macular thickness greater than the normal range for the OCT machine being used, regardless of the presence of cysts, as assessed by study ophthalmologist;
- Best corrected visual acuity (BCVA) 5/200 or better;
- Baseline intraocular pressure > 5 mm Hg and ≤ 21 mm Hg (current use of 3 or fewer intraocular pressure-lowering medications and/or prior glaucoma surgery are acceptable);
Key exclusion criteria (17 listed)
- -History of infectious uveitis, or of scleritis, keratitis, or infectious endophthalmitis in either eye;
- History of central serous retinopathy in either eye;
- For women of childbearing potential: pregnancy, breastfeeding, or a positive pregnancy test; unwilling to practice an adequate birth control method (abstinence, combination barrier and spermicide, or hormonal) for duration of trial;
- Use of oral acetazolamide or other systemic carbonic anhydrase inhibitor at baseline;
- Oral prednisone dose > 10 mg per day (or of an alternative corticosteroid at a dose higher than that equipotent to prednisone 10 mg per day) OR oral prednisone dose ≤ 10 mg per day that has not been stable for at least 4 weeks(note that if patient is off of oral prednisone at baseline (P01 visit), dose stability requirement for past 4 weeks does not apply);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Periocular triamcinolone 40 mgAlso: KenalogPeriocular triamcinolone acetonide, 40 mg injection may be given either by posterior sub-Tenon's approach or by the orbital floor approach, as both appear to have similar efficacy; the approach to the periocular injection will be recorded for analysis if needed. | Drug | Periocular triamcinolone 40mg |
| Intravitreal triamcinolone 4 mgAlso: Triescence (in U.S); Kenalog allowed at non-U.S. clinicsIntravitreal triamcinolone acetonide, 4 mg injection procedures should be carried out under controlled aseptic conditions which include the use of sterile gloves and a sterile eyelid speculum (or equivalent). Adequate anesthesia and a broad-spectrum microbicide such as betadine, applied to the periocular skin, eyelid and ocular surface are required prior to an intravitreal injection. | Drug | Intravitreal triamcinolone 4mg |
| Dexamethasone intravitreal implantAlso: Ozurdex• Standard preparation as described for intravitreal injections. | Drug | Dexamethasoneintravitreal implant |
Primary outcome
Proportion of Baseline Central Subfield Thickness Observed at 8 Weeks
Time frame: At baseline and 8 weeks
The primary outcome is the change in central subfield thickness from baseline to 8 weeks measured on a relative scale as the the proportion of the baseline central subfield thickness. Values less than 1 indicate a decrease in retinal thickness with lower values indicating greater decreases. Smaller values are better. The time point of 8 weeks was chosen for assessment of the primary outcome because it encompasses the window for maximum benefit for all three treatment strategies. Retinal thickness was evaluated using masked assessments of OCT images.
14 secondary outcomes
Proportion of Baseline Central Subfield Thickness Observed at 24 Weeks
Time frame: At baseline and the 24 week visit
Proportion of Eyes With >= 20% Reduction in Macular Thickness (or Normalization Even if <20% Reduction) at 8 Weeks
Time frame: Over 8 weeks of follow-up
Proportion of Eyes With >= 20% Reduction in Macular Thickness (or Normalization Even if <20% Reduction) at 24 Weeks
Time frame: Over 24 weeks of follow-up
Proportion of Eyes With Resolution of Macular Edema at 8 Weeks
Time frame: Over 8 weeks of follow-up
Proportion of Eyes With Resolution of Macular Edema at 24 Weeks
Time frame: Over 24 weeks of follow-up
Change in Best-corrected Visual Acuity at 8 Weeks
Time frame: Over 8 weeks of follow-up
Change in Best-corrected Visual Acuity at 24 Weeks
Time frame: Over 24 weeks of follow-up
Number of Eyes With Vitreous Hemorrhage
Time frame: During 24 weeks of follow-up
Number of Eyes With Retinal Tear or Detachment
Time frame: During 24 weeks of follow-up
Number of Eyes With Endophthalmitis
Time frame: During 24 weeks of folllow-ip
Cumulative Proportion of Eyes With Severe Vision Loss
Time frame: During 24 weeks of follow-up
Cumulative Proportion of Eyes With an IOP Elevation of >=10 mm Hg Over Baseline
Time frame: During 24 weeks of follow-up
Cumulative Proportion of Eyes With an IOP Elevation >=24 mm Hg
Time frame: During 24 weeks of follow-up
Cumulative Proportion of Eyes With an IOP Elevation >=30 mm Hg
Time frame: During 24 weeks of follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 30269924Thorne JE, Sugar EA, Holbrook JT, Burke AE, Altaweel MM, Vitale AT, Acharya NR, Kempen JH, Jabs DA; Multicenter Uveitis Steroid Treatment Trial Research Group. Periocular Triamcinolone vs. Intravitreal Triamcinolone vs. Intravitreal Dexamethasone Implant for the Treatment of Uveitic Macular Edema: The PeriOcular vs. INTravitreal corticosteroids for uveitic macular edema (POINT) Trial. Ophthalmology. 2019 Feb;126(2):283-295. doi: 10.1016/j.ophtha.2018.08.021. Epub 2018 Sep 27.
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Efficacy of Aflibercept (8 mg) With Sequential Laser Photocoagulation for Macular Edema Secondary to Retinal Artery Macroaneurysm: Retrospective Study"
Retinal Arterial Macroaneurysm
Active, not recruitingPhase 2
Long-Term Follow-Up Study of RGX-314 Administered in the Suprachoroidal Space for Participants With and Without Diabetic Retinopathy
Diabetic Retinopathy, DR
RecruitingPhase 3
A Phase 3 Trial for Intravitreal Injection of 4D-150 in Adults With Diabetic Macular Edema (DME).
Diabetic Macular Edema (DME)
RecruitingPhase 2
Oral N-Acetylcysteine on Diabetic Macular Edema
Diabetic Macular Edema (DME)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Douglas A Jabs, MD, MBA study chair
Icahn School of Medicine, Noutn Sinai, New York, NY
26 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Periocular triamcinolone 40 mg, Intravitreal triamcinolone 4 mg and Dexamethasone intravitreal implant in people with Macular Edema and Uveitis, run by JHSPH Center for Clinical Trials at 26 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in United States, Australia, Canada, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Baseline Central Subfield Thickness Observed at 8 Weeks (time frame: At baseline and 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02374060, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2018.