Ozurdex for Combined Pseudophakic Cystoid Macular Edema and Diabetic Macular Edema After Cataract Surgery

Northern California Retina Vitreous Associates

Status and phase: Completed; Phase 2

Conditions: Pseudophakic Cystoid Macular Edema,; Diabetic Macular Edema

Treatments: Drug: Dexamethasone Implant

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01284478

NCRVA-2011-Ozurdex-16-1

Details and patient eligibility

About

The purpose of the study is to determine where a sustained steroid delivery system (Ozurdex,Allergan) is safe and effective to treat Cystoid Macular Edema in diabetic patients after Cataract Surgery

Enrollment: 6 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• DIABETIC PATIENTS WHO DEVELOP CYSTOID MACULA EDEMA AFTER CATARACT SURGERY (WITHIN 4-10 WEEKS AFTER SURGERY
• VISUAL ACUITY WORSE THAN 20/32

Exclusion criteria

• VISUAL ACUITY WORSE THAN 20/200
• MODERATE OR SEVERE GLAUCOMA (AS DEFINED AS USING >2 TOPICAL GLAUCOMA MEDIATIONS.
• USE OF SYSTEMIC, PERIOCULAR OR INTRAOCULAR CORTICOSTEROIDS WITHIN 30 DAYS OF ENROLLMENT

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

6 participants in 1 patient group

Dexamethasone Implant

Other group

Description:

Patients will be treated with the Ozurdex (Dexamethasone Implant)

Treatment:

Drug: Dexamethasone Implant