A Phase 2 Evaluation of Anti-VEGF Therapy for Diabetic Macular Edema: Bevacizumab (Avastin)

Conditions

• Diabetic Retinopathy

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Laser Photocoagulation — PROCEDURE
  Laser photocoagulation at baseline; If edema present at 12 weeks, can be treated with 2 intravitreal injections of 1.25 mg bevacizumab spaced 6 weeks apart
• Bevacizumab — DRUG
  1.25 mg intravitreal injection of bevacizumab at baseline and 6 weeks
• Bevacizumab — DRUG
  2.5 mg intravitreal injection of bevacizumab at baseline and 6 weeks
• Bevacizumab — DRUG
  1.25 mg intravitreal injection of bevacizumab at baseline (sham injection at 6 weeks)
• Bevacizumab — DRUG
  1.25 mg intravitreal injection of bevacizumab at baseline, laser photocoagulation at 3 weeks, and intravitreal injection of 1.25 mg bevacizumab at 6 weeks

Study Details

This study will provide preliminary data on the dose and dose interval related effects of intravitreally administered Avastin on retinal thickness and visual acuity in subjects with Diabetic Macular Edema (DME) to aid in planning a phase 3 trial. In addition, this study will provide preliminary data on the safety of intravitreally administered Avastin in subjects with DME.

Key Dates

First listed

Jun 13, 2006

Start date

Jun 30, 2006

Status verified

Aug 2016

Primary completion

Nov 30, 2006

Completion

Feb 29, 2008

Study Design

Enrollment

121 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: 1
  Laser photocoagulation at baseline
• Experimental: 2
  1.25 mg intravitreal injection of bevacizumab at baseline and 6 weeks
• Experimental: 3
  2.5 mg intravitreal injection of bevacizumab at baseline and 6 weeks
• Experimental: 4
  1.25 mg intravitreal injection of bevacizumab at baseline (sham injection at 6 weeks)
• Experimental: 5
  1.25 mg intravitreal injection of bevacizumab at baseline, laser photocoagulation at 3 weeks, and intravitreal injection of 1.25 mg bevacizumab at 6 weeks

Primary Outcome Measure

Change in Central Subfield Retinal Thickness From Baseline Over All Study Visits [ Time Frame: Baseline to 3,6,9, and 12 weeks ]

Locations (34)

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