Ranibizumab for Treatment of Persistent Diabetic Neovascularization Assessed by Wide-Field Imaging

Conditions

• Proliferative Diabetic Retinopathy

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• ranibizumab — DRUG
  One 0.5 mg intravitreal injection
• Laser photocoagulation — PROCEDURE
  panretinal photocoagulation (up to 500 300-500 um laser spots)

Study Details

Diabetic neovascularization refers to a type of diabetic retinopathy which is worsening by the abnormal growth of blood vessels in the back of the eye, damaging the retina. The usual treatment is a type of laser, called panretinal photocoagulation. One drawback is that the amount of space within the eye for use of this treatment eventually has its limit, and should not be used too near the part of the retina used for detailed vision (the macula). In similar eye disorders, there are certain injectable medications called anti-VEGF treatments which can slow down or stop this abnormal blood vessel growth. This study sought to compare use of ranibizumab versus standard panretinal photocoagulation in treatment of diabetic neovascularization.

Key Dates

First listed

Feb 1, 2008

Start date

Jan 31, 2008

Status verified

Apr 2023

Primary completion

Oct 31, 2010

Completion

Oct 31, 2010

Study Design

Enrollment

9 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Anti-VEGF injection
  Intravitreal injection of 0.5-mg dose of ranibizumab
• Active Comparator: PRP Laser
  Additional panretinal photocoagulation (up to 500 300-500 um laser spots)

Primary Outcome Measure

The Mean Percentage Change of the Area of the Patient's Neovascularization as Measured in Pixels by Optomap FA (Fluorescein Angiography) [ Time Frame: Baseline to Week 4; Baseline to Month 4-6 ]

Locations (1)

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