Intravitreal Ranibizumab to Treat Macular Edema After Panretinal Photocoagulation (Phase II)

Conditions

• Macular Edema
• Proliferative Diabetic Retinopathy

Eligibility Criteria

Sex

ALL

Age

21 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• ranibizumab — DRUG
  Ranibizumab 0.5mg at baseline and then again at 30 days and/or 60 days after PRP as deemed appropriate by the Investigator.

Study Details

This is a randomized, open-label Phase II study evaluating the safety and efficacy of intravitreally administered ranibizumab 0.5mg in subjects with Proliferative Diabetic Retinopathy experiencing post- Panretinal Photocoagulation (PRP) macular edema.

Key Dates

First listed

Apr 29, 2008

Start date

Mar 31, 2007

Status verified

Feb 2019

Primary completion

Jun 30, 2010

Completion

Mar 31, 2012

Study Design

Enrollment

6 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Ranibizumab
  Ranibizumab is being used off-label to test the safety and efficacy of its use in Diabetic Macular Edema post panretinal photocoagulation. Ranibizumab 0.5mg at baseline and then again at 30 days and/or 60 days after PRP as deemed appropriate by the Investigator.

Primary Outcome Measure

Mean Change From Pre-PRP Best Corrected Visual Acuity (BCVA) at 3 Months as Expressed as an Early Treatment Diabetic Retinopathy Study (ETDRS) Score (Number of Letters Correctly Read.) [ Time Frame: March 2010 ]

Locations (1)

Find similar trials in San Francisco, CA

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  PHASE2 · Recruiting · Boehringer Ingelheim · Arcadia, California