Macular Edema Clinical Trial
— DEMOOfficial title:
Intravitreal Dexamethasone Implant for Persistent Macular Thickening and Edema After Vitrectomy for Epiretinal Membrane: A Pilot Study
Verified date | October 2018 |
Source | Wills Eye |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 3 |
Est. completion date | September 14, 2017 |
Est. primary completion date | September 14, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility |
Inclusion Criteria: 1. Patient of the Wills Eye Institute Retina service, including all Mid-Atlantic Retina offices 2. Volunteer patients age 18 years and older 3. Healthy enough to participate in the study 4. Willing and able to consent to participation in the study 5. History of pars plan vitrectomy for symptomatic epiretinal membrane at least 3 months prior to study enrollment date 6. BCVA of 20/40 or worse 7. CMT of at least 400 micrometers with or without cystoid macular edema on SD-OCT 8. Prior treatment with topical NSAIDs without resolution of macular thickening or visual acuity improvement Exclusion Criteria: 1. Advanced glaucoma (cup-disc ratio of 0.8 or greater) 2. History of glaucoma filtering or tube shunt implant surgery 3. Steroid responsive intraocular hypertension 4. Diabetic retinopathy 5. History of uveitis 6. Use of systemic or intraocular corticosteroids 7. Active or suspected ocular or periocular infections 8. Other confounding intraocular pathology |
Country | Name | City | State |
---|---|---|---|
United States | Mid Atlantic Retina | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Wills Eye | Mid Atlantic Retina |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mean central macular thickness (CMT) on SD-OCT at 1 month, 3 months, and 6 months after intravitreal injection of dexamethasone implant | Change in mean macular thickness baseline at 6 months | ||
Secondary | Visual acuity | Change in visual acuity baseline at 6 months |
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