Intravitreal Dexamethasone Implant for Persistent Macular Thickening and Edema After Vitrectomy for Epiretinal Membrane

• Status: Terminated
• Trial end date: 2017-09-14
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Wills Eye
• Collaborator: Mid Atlantic Retina
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate

Criteria

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