Macular EdemaDEMONCT02995746
Intravitreal Dexamethasone Implant for Persistent Macular Thickening and Edema After Vitrectomy for Epiretinal Membrane
A study testing Dexamethasone in people with Macular Edema and Epiretinal Membrane, run by Wills Eye at 1 site in United States.
Trial summary
This study seeks to evaluate the effect of the intravitreal 0.7mg dexamethasone implant on central macular thickness and visual acuity in those patients with persistent macular edema after pars plana vitrectomy for epiretinal membrane. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Macular Edema, Epiretinal Membrane, Vitrectomy
- What is being tested?
- Dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jan 2016to 14 Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient of the Wills Eye Institute Retina service, including all Mid-Atlantic Retina offices
- Volunteer patients age 18 years and older
- Healthy enough to participate in the study
- Willing and able to consent to participation in the study
- History of pars plan vitrectomy for symptomatic epiretinal membrane at least 3 months prior to study enrollment date
- BCVA of 20/40 or worse
- CMT of at least 400 micrometers with or without cystoid macular edema on SD-OCT
- Prior treatment with topical NSAIDs without resolution of macular thickening or visual acuity improvement
Who cannot join
- Advanced glaucoma (cup-disc ratio of 0.8 or greater)
- History of glaucoma filtering or tube shunt implant surgery
- Steroid responsive intraocular hypertension
- Diabetic retinopathy
- History of uveitis
- Use of systemic or intraocular corticosteroids
- Active or suspected ocular or periocular infections
- Other confounding intraocular pathology
Trial locations and contacts
1 site in 1 country.
United States1 site
Mid Atlantic Retina
Philadelphia, Pennsylvania, 19107
About this study
Official title: Intravitreal Dexamethasone Implant for Persistent Macular Thickening and Edema After Vitrectomy for Epiretinal Membrane: A Pilot Study
This study seeks to evaluate the effect of the intravitreal 0.7mg dexamethasone implant on central macular thickness and visual acuity in those patients with persistent macular edema after pars plana vitrectomy for epiretinal membrane.
Read the detailed description
Macular edema is a relatively common occurrence after pars plana vitrectomy. Kim et al described that 47% of eyes undergoing vitrectomy for epiretinal membrane, macular hole, or vitreous hemorrhage had evidence of macular thickening on optical coherence tomography scan.1 Post-vitrectomy macular edema can limit potential visual acuity gain from removal of a symptomatic epiretinal membrane. Typical treatment of post-operative macular edema consists of topical non-steroidal anti-inflammatory drugs (NSAIDs) and topical corticosteroids; however, there are still resistant cases with refractory macular thickening.
The dexamethasone intravitreal implant (Ozurdex; Allergan, Irvine, CA) is currently FDA-approved for the treatment of posterior uveitis as well as macular edema secondary to retinal vein occlusion and diabetic retinopathy. Furino et al reported a retrospective series describing how a single injection of the 0.7mg dexamethasone intravitreal implant resulted in a substantial increase in best-corrected visual acuity (BCVA) and a decrease in central macular thickness (CMT) on spectral-domain optical coherence tomography (SD-OCT) in 8 patients with persistent macular thickening after pars plana vitrectomy for epiretinal membrane. There has been no prospective study evaluating the efficacy of this pharmacologic agent in this setting.
As such, the purpose of this study is to prospectively evaluate the effect of the intravitreal 0.7mg dexamethasone implant on CMT and BCVA in those patients with persistent macular edema after pars plana vitrectomy for epiretinal membrane.
The results of this study will help delineate whether the intravitreal dexamethasone implant has efficacy in improving CMT and/or visual acuity in those patients with refractory macular thickening after pars plana vitrectomy for epiretinal membrane.
- Conditions
- Macular Edema, Epiretinal Membrane, Vitrectomy
- Being tested
- Dexamethasone
- Medical subject headings
- Macular Edema, Epiretinal Membrane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Also called Ozurdex
- On study visit #1 all patients will have a SD-OCT scan and measurement of baseline visual acuity. All patients will receive the 0.7mg dexamethasone intravitreal implant
- Subsequent follow-up visits will be at 1 month, 2 months, 3 months, 4 months, 5 months, and 6 months after intravitreal injection of dexamethasone implant
- Each visit will consist of measurement of visual acuity, intraocular pressure, dilated fundoscopic examination, and SD-OCT scan
- Anticipated duration of the study: 6 months
| Study group | Role | What they receive |
|---|---|---|
| 0.7mg dexamethasone intravitreal implant | Experimental | Single intravitreal implantation of 0.7mg dexamethasone with a six month follow up period Receives: Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean central macular thickness (CMT) on SD-OCT at 1 month, 3 months, and 6 months after intravitreal injection of dexamethasone implant
Measured: Change in mean macular thickness baseline at 6 months
Secondary outcomes (1)
Visual acuity
Measured: Change in visual acuity baseline at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2016 (estimated)
- Study start28 Jan 2016
- Primary completion14 Sep 2017
- Study completion14 Sep 2017
Why it stopped: Terminated due to lack of drug efficacy. 2017 study did not show benefit.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wills Eye
- Sponsor type
- University, hospital or other
- Collaborators
- Mid Atlantic Retina
- Responsible party
- Principal investigator, Allen C. Ho, MD, Wills Eye
- Investigators
- Allen C Ho, MD, Principal investigator, Mid Atlantic Retina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02995746
- Sponsor's protocol ID
- 15-475
- Acronym
- DEMO
- Status last verified
- Oct 2018
- First submitted
- 14 Sep 2016
- Last updated
- 3 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravitreal Dexamethasone Implant for Persistent Macular Thickening and Edema After Vitrectomy for Epiretinal Membrane: A Pilot Study
- ClinicalTrials.gov ID
- NCT02995746
- Acronym / sponsor ID
- DEMO / 15-475
- Conditions
- Macular Edema, Epiretinal Membrane, Vitrectomy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated due to lack of drug efficacy. 2017 study did not show benefit.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Wills EyeUniversity, hospital or other
- Collaborators
- Mid Atlantic Retina
- Study start
- 28 Jan 2016 (actual)
- Primary completion
- 14 Sep 2017 (actual)
- Study completion
- 14 Sep 2017 (actual)
- First posted
- 16 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study seeks to evaluate the effect of the intravitreal 0.7mg dexamethasone implant on central macular thickness and visual acuity in those patients with persistent macular edema after pars plana vitrectomy for epiretinal membrane.
Detailed description
Macular edema is a relatively common occurrence after pars plana vitrectomy. Kim et al described that 47% of eyes undergoing vitrectomy for epiretinal membrane, macular hole, or vitreous hemorrhage had evidence of macular thickening on optical coherence tomography scan.1 Post-vitrectomy macular edema can limit potential visual acuity gain from removal of a symptomatic epiretinal membrane. Typical treatment of post-operative macular edema consists of topical non-steroidal anti-inflammatory drugs (NSAIDs) and topical corticosteroids; however, there are still resistant cases with refractory macular thickening.
The dexamethasone intravitreal implant (Ozurdex; Allergan, Irvine, CA) is currently FDA-approved for the treatment of posterior uveitis as well as macular edema secondary to retinal vein occlusion and diabetic retinopathy. Furino et al reported a retrospective series describing how a single injection of the 0.7mg dexamethasone intravitreal implant resulted in a substantial increase in best-corrected visual acuity (BCVA) and a decrease in central macular thickness (CMT) on spectral-domain optical coherence tomography (SD-OCT) in 8 patients with persistent macular thickening after pars plana vitrectomy for epiretinal membrane. There has been no prospective study evaluating the efficacy of this pharmacologic agent in this setting.
As such, the purpose of this study is to prospectively evaluate the effect of the intravitreal 0.7mg dexamethasone implant on CMT and BCVA in those patients with persistent macular edema after pars plana vitrectomy for epiretinal membrane.
The results of this study will help delineate whether the intravitreal dexamethasone implant has efficacy in improving CMT and/or visual acuity in those patients with refractory macular thickening after pars plana vitrectomy for epiretinal membrane.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 0.7mg dexamethasone intravitreal implant | Experimental | Drug: DexamethasoneSingle intravitreal implantation of 0.7mg dexamethasone with a six month follow up period |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient of the Wills Eye Institute Retina service, including all Mid-Atlantic Retina offices
- Volunteer patients age 18 years and older
- Healthy enough to participate in the study
- Willing and able to consent to participation in the study
- History of pars plan vitrectomy for symptomatic epiretinal membrane at least 3 months prior to study enrollment date
Key exclusion criteria (8 listed)
- Advanced glaucoma (cup-disc ratio of 0.8 or greater)
- History of glaucoma filtering or tube shunt implant surgery
- Steroid responsive intraocular hypertension
- Diabetic retinopathy
- History of uveitis
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 |
|---|---|---|
| DexamethasoneAlso: Ozurdex* On study visit #1 all patients will have a SD-OCT scan and measurement of baseline visual acuity. All patients will receive the 0.7mg dexamethasone intravitreal implant * Subsequent follow-up visits will be at 1 month, 2 months, 3 months, 4 months, 5 months, and 6 months after intravitreal injection of dexamethasone implant * Each visit will consist of measurement of visual acuity, intraocular pressure, dilated fundoscopic examination, and SD-OCT scan * Anticipated duration of the study: 6 months | Drug | 0.7mg dexamethasone intravitreal implant |
Primary outcome
Mean central macular thickness (CMT) on SD-OCT at 1 month, 3 months, and 6 months after intravitreal injection of dexamethasone implant
Time frame: Change in mean macular thickness baseline at 6 months
1 secondary outcome
Visual acuity
Time frame: Change in visual acuity baseline at 6 months
Results and safety
The study was stopped early (reason given: Terminated due to lack of drug efficacy. 2017 study did not show benefit.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2018.
- Individual participant dataSharing planned: No
Related trials for Macular Edema
Active, not recruitingObservational study
Real World Evidence in China: Faricimab Use in Diabetic Macular Edema, Retinal Vein Occlusion, and Neovascular Age-Related Macular Degeneration (The Farseeing Study)
Diabetic Macular Edema, Neovascular Age-related Macular Degeneration
Not yet recruitingObservational study
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.
Allen C Ho, MD principal investigator
Mid Atlantic Retina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexamethasone in people with Macular Edema and Epiretinal Membrane, run by Wills Eye 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 8 inclusion and 8 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: stopped early, as of the sponsor's last update on 3 Oct 2018. 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.
Are results available for this study?
The study was stopped early (reason given: Terminated due to lack of drug efficacy. 2017 study did not show benefit.). Results are not available in the source record.
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?
Mean central macular thickness (CMT) on SD-OCT at 1 month, 3 months, and 6 months after intravitreal injection of dexamethasone implant (time frame: Change in mean macular thickness baseline at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Oct 2018.