Laser-Ranibizumab-Triamcinolone for Diabetic Macular Edema

Conditions

• Diabetic Macular Edema
• Diabetic Retinopathy

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Triamcinolone Acetonide + laser — DRUG
  4 mg intravitreal triamcinolone at randomization plus focal photocoagulation 1 week post-injection, repeated every 16 weeks with sham injections at 4-week intervals in-between. Retreatment starting at 16 weeks depends on visual acuity and OCT.
• Ranibizumab + laser — DRUG
  0.5 mg intravitreal ranibizumab at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
• Sham injection + laser — DRUG
  Sham injection at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
• Ranibizumab + deferred laser — DRUG
  0.5 mg intravitreal ranibizumab at randomization, repeated every 4 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT. If improvement has not occured from injections alone, laser can be given starting at the 24 week visit.

Study Details

The purpose of the study is to find out which is a better treatment for diabetic macular edema (DME): laser alone, laser combined with an intravitreal injection of triamcinolone, laser combined with an intravitreal injection of ranibizumab, or intravitreal injection of ranibizumab alone. At the present time, it is not known whether intravitreal steroid or anti-vascular endothelial growth factor (anti-VEGF) injections, with or without laser treatment, are better than just laser by itself. It is possible that one or both of the types of injections, with or without laser treatment, will improve vision more often than will laser without injections. However, even if better vision outcomes are seen with injections, side effects may be more of a problem with the injections than with laser. Therefore, this study is conducted to find out whether the benefits of the injections will outweigh the risks.

Key Dates

First listed

Mar 8, 2007

Start date

Mar 31, 2007

Status verified

Sep 2019

Primary completion

Dec 31, 2009

Completion

Feb 28, 2014

Study Design

Enrollment

691 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: 0.5mg Ranibizumab plus laser
• Experimental: 0.5 mg Ranibizumab plus deferred laser
• Experimental: 4 mg Triamcinolone plus laser
• Active Comparator: Sham plus laser

Primary Outcome Measure

Mean Change in Visual Acuity (Letters) From Baseline to 1 Year Adjusted for Baseline Visual Acuity [ Time Frame: from baseline to 1 Year ]

Locations (50)

Find similar trials in Artesia, CA

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