Retinal Vein OcclusionPhase 4PERMEATENCT02503540
Peripheral and Macular Retinal Vascular Perfusion and Leakage in DME and RVO
A Phase 4 study testing Aflibercept in people with Retinal Vein Occlusion and Diabetic Macular Edema, run by Justis Ehlers at 1 site in United States.
Trial summary
This interventional study will evaluate the retinal vascular dynamics associated with Intravitreal Aflibercept Injection (IAI) therapy in eyes with diabetic macular edema (DME) or macular edema secondary to retinal vein occlusion (RVO). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Retinal Vein Occlusion, Diabetic Macular Edema, Branch Retinal Vein Occlusion
- What is being tested?
- Aflibercept
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Aug 2015to 6 Feb 2018
- Phase
- Phase 4
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A subject must meet the following criteria to be eligible for inclusion in the study:
- Signed Informed Consent.
- Men and women ≥ 18 years of age.
- Foveal-involving retinal edema secondary to DME or RVO based on investigator review of SDOCT.
- E-ETDRS best-corrected visual acuity of: 20/25 to 20/400 in the study eye or Hand Motion (HM) in the study eye.
- Willing, committed, and able to return for all clinic visits and complete all study related procedures.
- Able to read, (or, if unable to read due to visual impairment, be read to verbatim by the person administering the informed consent or a family member) understand and willing to sign the informed consent form.
Who cannot join
- A subject who meets any of the following criteria will be excluded from the study:
- Any prior or concomitant therapy with another investigational agent to treat DME or RVO in the study eye.
- Prior panretinal photocoagulation in the study eye.
- Prior intravitreal anti-VEGF therapy in the study eye.
- Prior focal/grid laser photocoagulation in the study eye.
- Prior history of intravitreal steroid therapy in the study eye.
Show all 35Show fewer
- Any history of allergy to fluorescein sodium or other reason that the patient is unable to undergo fluorescein angiography (e.g., inability to get vascular access, unable to tolerate procedure)
- Prior systemic anti-VEGF therapy, investigational or FDA-approved, is only allowed up to 3 months prior to first dose, and will not be allowed during the study.
- Significant vitreous hemorrhage obscuring view to the macula or the retinal periphery as determined by the investigator on clinical exam and ultra-widefield angiography.
- Presence of other causes of macular edema, including myopic degeneration, ocular histoplasmosis syndrome, angioid streaks, choroidal rupture, choroidal neovascularization, neovascular age-related macular degeneration or multifocal choroiditis in the study eye. Epiretinal membranes are allowed.
- Presence of macula-threatening traction retinal detachment.
- Prior vitrectomy in the study eye.
- History of retinal detachment or treatment or surgery for retinal detachment in the study eye.
- Any history of macular hole of stage 2 and above in the study eye.
- Any intraocular or periocular surgery within 3 months of Day 1 on the study eye, except lid surgery, which may not have taken place within 1 month of day 1, as long as it's unlikely to interfere with the injection.
- Prior trabeculectomy or other filtration surgery in the study eye.
- Uncontrolled glaucoma at baseline evaluation (defined as intraocular pressure ≥25 mmHg despite treatment with anti-glaucoma medication) in the study eye.
- Active intraocular inflammation in either eye.
- Active ocular or periocular infection in either eye.
- Any ocular or periocular infection within the last 2 weeks prior to Screening in either eye.
- Any history of uveitis in either eye.
- Active scleritis or episcleritis in either eye.
- Presence or history of scleromalacia in either eye.
- Aphakia in the study eye.
- Previous therapeutic radiation in the region of the study eye.
- History of full-thickness penetrating keratoplasty in the study eye. Partial thickness corneal transplants including Descemet stripping automated endothelial keratoplasty and Descemet membrane endothelial keratoplasty are allowed.
- Significant media opacities, including cataract, in the study eye which might interfere with visual acuity, assessment of safety, or fundus photography.
- Any concurrent intraocular condition in the study eye (e.g. cataract) that, in the opinion of the investigator, could require either medical or surgical intervention during the 52 week study period.
- Any concurrent ocular condition in the study eye which, in the opinion of the investigator, could either increase the risk to the subject beyond what is to be expected from standard procedures of intraocular injection, or which otherwise may interfere with the injection procedure or with evaluation of efficacy or safety.
- Participation as a subject in any clinical study within the 12 weeks prior to Day 1.
- Any systemic therapy with an investigational agent in the past 3 months prior to Day 1.
- Any history of allergy to povidone iodine.
- Pregnant or breast-feeding women
- Women of childbearing potential* who are unwilling to practice adequate contraception during the study (adequate contraceptive measures include stable use of oral contraceptives or other prescription pharmaceutical contraceptives for 2 or more menstrual cycles prior to screening; intrauterine device (IUD); bilateral tubal ligation; vasectomy; condom plus contraceptive sponge, foam, or jelly, or diaphragm plus contraceptive sponge, foam, or jelly)
- Postmenopausal women must be amenorrheic for at least 12 months in order not to be considered of child bearing potential. Pregnancy testing and contraception are not required for women with documented hysterectomy or tubal ligation.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cole Eye Institute, Cleveland Clinic
Cleveland, Ohio, 44195
About this study
Official title: Peripheral and Macular Retinal Vascular Perfusion and Leakage Dynamics in Diabetic Macular Edema and Retinal Venous Occlusions During Intravitreal Aflibercept Injection (IAI) Treatment for Retinal Edema: PERMEATE Study
This interventional study will evaluate the retinal vascular dynamics associated with Intravitreal Aflibercept Injection (IAI) therapy in eyes with diabetic macular edema (DME) or macular edema secondary to retinal vein occlusion (RVO). Ultra-widefield fluorescein angiography and optical coherence tomography (OCT) angiography will be performed at multiple timepoints to assess the changes in retinal vascular leakage, ischemia, and vascular abnormalities throughout the study duration and compare these alterations to baseline.
Read the detailed description
Diabetic macular edema (DME) and macular edema secondary to retinal venous occlusive diseases are the most common cause of vision loss from a retinal vascular disease. Recently, vascular endothelial growth factor (VEGF) inhibitors (bevacizumab, aflibercept, and ranibizumab) have been described as new first-line therapies for these conditions. Aflibercept is the most recently approved VEGF inhibitor for the management of these conditions. Clinical trials have shown that treatment with aflibercept improves visual acuity and reduces macular edema in a large percentage of patients.
This study will examine the changes that occur with intravitreal aflibercept to perfusion and leakage in treatment naive eyes over the course of 1 year.
- Conditions
- Retinal Vein Occlusion, Diabetic Macular Edema, Branch Retinal Vein Occlusion, Central Retinal Vein Occlusion
- Being tested
- Aflibercept
- Keywords
- macular edema, rvo, diabetic macular edema
- Medical subject headings
- Retinal Vein Occlusion, Macular Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AfliberceptDrug
Also called Eylea
Intravitreal aflibercept will be given q4 wks for 6 treatments and then q 8 weeks through month 12.
| Study group | Role | What they receive |
|---|---|---|
| Aflibercept | Other | Monthly aflibercept for 6 months and then every other month for 6 months. Receives: Drug: Aflibercept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Panretinal Leakage Index at Month 12 From Baseline
Change in panretinal leakage index (defined as the proportion of retinal area involved in angiographic leakage) at month 12 from baseline as measured by ultra-widefield angiography (UWFA).
Measured: 12 months
Secondary outcomes (16)
Mean Change in Total Leakage Index
Mean change in total leakage index from baseline to month 6
Measured: 6 months
Change in Panretinal Ischemic Index
Change in panretinal ischemic index from baseline to postoperative month 12
Measured: 12 months
Change in Panretinal Ischemic Index From Baseline at 6 Months
Change in panretinal ischemic index (defined as the proportion of retinal area with nonperfusion) from baseline at 6 months
Measured: 6 months
Mean Change From Baseline Central Subfield Thickness
OCT central subfield thickness change from baseline to 6 months
Measured: 6 months
Mean Change From Baseline in Best-corrected Visual Acuity (BCVA) Score Based on ETDRS
Mean change from baseline in best-corrected visual acuity (BCVA) score from baseline to month 12
Measured: 12 months
Number of Participants Who Gained 15 ETDRS Letters or More of Vision
Measured: 12 months
Number of Patients Who Gained 15 ETDRS Letters or More of Vision
Measured: 6 months
Number of Patients That Showed Visual Acuity 20/40 or Better
Measured: 6 months
Number of Patients That Showed Visual Acuity 20/200 or Worse
Measured: 6 months
Ocular Serious Adverse Events
Measured: 12 months
Number of Participants Who Lost 15 ETDRS Letters or More of Vision
Measured: 12 months
Number of Participants Who Lost 15 ETDRS Letters or More of Vision
Measured: 6 months
Number of Patients That Showed Visual Acuity 20/40 or Better
Measured: 12 months
Number of Patients That Showed Visual Acuity 20/200 or Worse
Measured: 12 months
Mean Change From Baseline Central Subfield Thickness
Measured: 12 months
Systemic Serious Adverse Events
Incidence of systemic SAEs
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2015 (estimated)
- Study start18 Aug 2015
- Primary completion6 Feb 2018
- Study completion6 Feb 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 (8)Papers the sponsor has linked to this study.
- Other trials for Retinal Vein OcclusionStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Justis Ehlers
- Sponsor type
- University, hospital or other
- Collaborators
- Regeneron Pharmaceuticals
- Responsible party
- Sponsor-investigator, Justis Ehlers, The Cleveland Clinic
- Investigators
- Justis P Ehlers, MD, Principal investigator, Cole Eye Institute, Cleveland Clinic, OH 44195
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02503540
- Sponsor's protocol ID
- 15-442
- Acronym
- PERMEATE
- Status last verified
- May 2021
- First submitted
- 17 Jul 2015
- Last updated
- 12 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Wessel MM, Nair N, Aaker GD, Ehrlich JR, D'Amico DJ, Kiss S. Peripheral retinal ischaemia, as evaluated by ultra-widefield fluorescein angiography, is associated with diabetic macular oedema. Br J Ophthalmol. 2012 May;96(5):694-8. doi: 10.1136/bjophthalmol-2011-300774. Epub 2012 Mar 15.
PubMed 22423055Thickett DR, Armstrong L, Millar AB. Vascular endothelial growth factor (VEGF) in inflammatory and malignant pleural effusions. Thorax. 1999 Aug;54(8):707-10. doi: 10.1136/thx.54.8.707.
PubMed 10413724Singer M, Tan CS, Bell D, Sadda SR. Area of peripheral retinal nonperfusion and treatment response in branch and central retinal vein occlusion. Retina. 2014 Sep;34(9):1736-42. doi: 10.1097/IAE.0000000000000148.
PubMed 24732695Rakic JM, Lambert V, Devy L, Luttun A, Carmeliet P, Claes C, Nguyen L, Foidart JM, Noel A, Munaut C. Placental growth factor, a member of the VEGF family, contributes to the development of choroidal neovascularization. Invest Ophthalmol Vis Sci. 2003 Jul;44(7):3186-93. doi: 10.1167/iovs.02-1092.
PubMed 12824270Ferrara N. Vascular endothelial growth factor and the regulation of angiogenesis. Recent Prog Horm Res. 2000;55:15-35; discussion 35-6.
PubMed 11036931Ferrara N, Houck KA, Jakeman LB, Winer J, Leung DW. The vascular endothelial growth factor family of polypeptides. J Cell Biochem. 1991 Nov;47(3):211-8. doi: 10.1002/jcb.240470305.
PubMed 1791185Ferrara N, Davis-Smyth T. The biology of vascular endothelial growth factor. Endocr Rev. 1997 Feb;18(1):4-25. doi: 10.1210/edrv.18.1.0287. No abstract available.
PubMed 9034784Figueiredo N, Srivastava SK, Singh RP, Babiuch A, Sharma S, Rachitskaya A, Talcott K, Reese J, Hu M, Ehlers JP. Longitudinal Panretinal Leakage and Ischemic Indices in Retinal Vascular Disease after Aflibercept Therapy: The PERMEATE Study. Ophthalmol Retina. 2020 Feb;4(2):154-163. doi: 10.1016/j.oret.2019.09.001. Epub 2019 Sep 10.
PubMed 31757691
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peripheral and Macular Retinal Vascular Perfusion and Leakage Dynamics in Diabetic Macular Edema and Retinal Venous Occlusions During Intravitreal Aflibercept Injection (IAI) Treatment for Retinal Edema: PERMEATE Study
- ClinicalTrials.gov ID
- NCT02503540
- Acronym / sponsor ID
- PERMEATE / 15-442
- Conditions
- Retinal Vein Occlusion, Diabetic Macular Edema, Branch Retinal Vein Occlusion, Central Retinal Vein Occlusion
- Keywords
- macular edema, rvo, diabetic macular edema
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Justis EhlersUniversity, hospital or other
- Collaborators
- Regeneron Pharmaceuticals
- Study start
- 18 Aug 2015 (actual)
- Primary completion
- 6 Feb 2018 (actual)
- Study completion
- 6 Feb 2018 (actual)
- First posted
- 21 Jul 2015 (estimated)
- Results
- Posted 12 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This interventional study will evaluate the retinal vascular dynamics associated with Intravitreal Aflibercept Injection (IAI) therapy in eyes with diabetic macular edema (DME) or macular edema secondary to retinal vein occlusion (RVO). Ultra-widefield fluorescein angiography and optical coherence tomography (OCT) angiography will be performed at multiple timepoints to assess the changes in retinal vascular leakage, ischemia, and vascular abnormalities throughout the study duration and compare these alterations to baseline.
Detailed description
Diabetic macular edema (DME) and macular edema secondary to retinal venous occlusive diseases are the most common cause of vision loss from a retinal vascular disease. Recently, vascular endothelial growth factor (VEGF) inhibitors (bevacizumab, aflibercept, and ranibizumab) have been described as new first-line therapies for these conditions. Aflibercept is the most recently approved VEGF inhibitor for the management of these conditions. Clinical trials have shown that treatment with aflibercept improves visual acuity and reduces macular edema in a large percentage of patients.
This study will examine the changes that occur with intravitreal aflibercept to perfusion and leakage in treatment naive eyes over the course of 1 year.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aflibercept | Other | Drug: AfliberceptMonthly aflibercept for 6 months and then every other month for 6 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Signed Informed Consent.
- Men and women ≥ 18 years of age.
- Foveal-involving retinal edema secondary to DME or RVO based on investigator review of SDOCT.
- E-ETDRS best-corrected visual acuity of: 20/25 to 20/400 in the study eye or Hand Motion (HM) in the study eye.
- Willing, committed, and able to return for all clinic visits and complete all study related procedures.
Key exclusion criteria (35 listed)
- Any prior or concomitant therapy with another investigational agent to treat DME or RVO in the study eye.
- Prior panretinal photocoagulation in the study eye.
- Prior intravitreal anti-VEGF therapy in the study eye.
- Prior focal/grid laser photocoagulation in the study eye.
- Prior history of intravitreal steroid therapy in the study eye.
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 |
|---|---|---|
| AfliberceptAlso: EyleaIntravitreal aflibercept will be given q4 wks for 6 treatments and then q 8 weeks through month 12. | Drug | Aflibercept |
Primary outcome
Change in Panretinal Leakage Index at Month 12 From Baseline
Time frame: 12 months
Change in panretinal leakage index (defined as the proportion of retinal area involved in angiographic leakage) at month 12 from baseline as measured by ultra-widefield angiography (UWFA).
16 secondary outcomes
Mean Change in Total Leakage Index
Time frame: 6 months
Change in Panretinal Ischemic Index
Time frame: 12 months
Change in Panretinal Ischemic Index From Baseline at 6 Months
Time frame: 6 months
Mean Change From Baseline Central Subfield Thickness
Time frame: 6 months
Mean Change From Baseline in Best-corrected Visual Acuity (BCVA) Score Based on ETDRS
Time frame: 12 months
Number of Participants Who Gained 15 ETDRS Letters or More of Vision
Time frame: 12 months
Number of Patients Who Gained 15 ETDRS Letters or More of Vision
Time frame: 6 months
Number of Patients That Showed Visual Acuity 20/40 or Better
Time frame: 6 months
Number of Patients That Showed Visual Acuity 20/200 or Worse
Time frame: 6 months
Ocular Serious Adverse Events
Time frame: 12 months
Number of Participants Who Lost 15 ETDRS Letters or More of Vision
Time frame: 12 months
Number of Participants Who Lost 15 ETDRS Letters or More of Vision
Time frame: 6 months
Number of Patients That Showed Visual Acuity 20/40 or Better
Time frame: 12 months
Number of Patients That Showed Visual Acuity 20/200 or Worse
Time frame: 12 months
Mean Change From Baseline Central Subfield Thickness
Time frame: 12 months
Systemic Serious Adverse Events
Time frame: 12 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22423055Wessel MM, Nair N, Aaker GD, Ehrlich JR, D'Amico DJ, Kiss S. Peripheral retinal ischaemia, as evaluated by ultra-widefield fluorescein angiography, is associated with diabetic macular oedema. Br J Ophthalmol. 2012 May;96(5):694-8. doi: 10.1136/bjophthalmol-2011-300774. Epub 2012 Mar 15.
- Background: PubMed 10413724Thickett DR, Armstrong L, Millar AB. Vascular endothelial growth factor (VEGF) in inflammatory and malignant pleural effusions. Thorax. 1999 Aug;54(8):707-10. doi: 10.1136/thx.54.8.707.
- Background: PubMed 24732695Singer M, Tan CS, Bell D, Sadda SR. Area of peripheral retinal nonperfusion and treatment response in branch and central retinal vein occlusion. Retina. 2014 Sep;34(9):1736-42. doi: 10.1097/IAE.0000000000000148.
- Background: PubMed 12824270Rakic JM, Lambert V, Devy L, Luttun A, Carmeliet P, Claes C, Nguyen L, Foidart JM, Noel A, Munaut C. Placental growth factor, a member of the VEGF family, contributes to the development of choroidal neovascularization. Invest Ophthalmol Vis Sci. 2003 Jul;44(7):3186-93. doi: 10.1167/iovs.02-1092.
- Background: PubMed 11036931Ferrara N. Vascular endothelial growth factor and the regulation of angiogenesis. Recent Prog Horm Res. 2000;55:15-35; discussion 35-6.
- Background: PubMed 1791185Ferrara N, Houck KA, Jakeman LB, Winer J, Leung DW. The vascular endothelial growth factor family of polypeptides. J Cell Biochem. 1991 Nov;47(3):211-8. doi: 10.1002/jcb.240470305.
- Background: PubMed 9034784Ferrara N, Davis-Smyth T. The biology of vascular endothelial growth factor. Endocr Rev. 1997 Feb;18(1):4-25. doi: 10.1210/edrv.18.1.0287. No abstract available.
- Derived from this study: PubMed 31757691Figueiredo N, Srivastava SK, Singh RP, Babiuch A, Sharma S, Rachitskaya A, Talcott K, Reese J, Hu M, Ehlers JP. Longitudinal Panretinal Leakage and Ischemic Indices in Retinal Vascular Disease after Aflibercept Therapy: The PERMEATE Study. Ophthalmol Retina. 2020 Feb;4(2):154-163. doi: 10.1016/j.oret.2019.09.001. Epub 2019 Sep 10.
- Individual participant dataSharing planned: No
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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.
Justis P Ehlers, MD principal investigator
Cole Eye Institute, Cleveland Clinic, OH 44195
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Aflibercept in people with Retinal Vein Occlusion and Diabetic Macular Edema, run by Justis Ehlers at 1 site in United States.
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 35 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 12 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 12 Feb 2020). 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?
Change in Panretinal Leakage Index at Month 12 From Baseline (time frame: 12 months). 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 NCT02503540, which also lists 8 linked publications.
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 12 May 2021.