Single Site, Masked, Randomized, Controlled Study to Assess Efficacy of Osurdex as Adjunct to Avastin Compared With Avastin Alone in the Treatment of Patients With Macular Edema Due to Central or Branch Retinal Vein Occlusion

Maturi, Raj K., M.D., P.C.

Status and phase: Completed; Phase 4

Conditions: Retinal Vein Occlusions

Treatments: Drug: Avastin; Drug: Osurdex

Study type: Interventional

Identifiers

NCT01085734

OA001

Details and patient eligibility

About

Comparative study to see if treating with Osurdex in addition to Avastin in patients with retinal vein occlusions helps increased visual acuity outcomes

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• male or female age 18 years or older
• Branch retinal vein occlusion or central retinal vein occlusion of less than one year duration
• Best correct visual acuity of greater than 24 and less than 80
• Presence of macular edema defined as OCT central subfield thickness of >250

Exclusion criteria

• intravitreal anti-VEGF treatment in study eye within six weeks of baseline
• intravitreal steroid treatment in the study eye within eight weeks of baseline visit
• PRP in the study eye within 4 month of baseline visit
• Active iris neovascularization in study eye
• Uncontrolled systemic disease
• Known history of IOP elevation in response to corticosteroid treatment that is not controlled on 2 glaucoma medications

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Group 1

Active Comparator group

Description:

Group 1 receives Avastin at baseline followed by sham Osurdex at week 1. Additional Avastin based on macular edema

Treatment:

Drug: Avastin

Drug: Avastin

Group 2

Active Comparator group

Description:

Group 2 receives Avastin at baseline followed by Osurdex at week 1. Retreatment with Avastin based on macular edema

Treatment:

Drug: Avastin

Drug: Osurdex

Drug: Avastin