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Bevacizumab Versus Ranibizumab in Treatment of Macular Edema From Vein Occlusion

NCT01428388 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2017-10-27

No results posted yet for this study

Summary

Antagonists of the vascular endothelial growth factor (VEGF) pathway are effective in treating macular edema resulting from retinal vein occlusion (RVO). In the eye, the two most widely used anti-VEGF agents are ranibizumab and bevacizumab. Only ranibizumab has been FDA-approved for the treatment of macular edema from RVO, however bevacizumab has been used off-label by many ophthalmologists with good success. Furthermore, the cost of bevacizumab is less than one-tenth the cost of ranibizumab. Here the investigators conduct a six month randomized, prospective interventional trial comparing the effectiveness of ranibizumab with bevacizumab in the treatment of macular edema from RVO. Primary outcome measures are change in central retinal thickness. Secondary measures are change in visual acuity from baseline and change in angiographic properties of macular lesions from baseline after treatment.

Conditions

  • Retinal Vein Occlusion
  • Macular Edema

Interventions

DRUG

Intravitreal injection of bevacizumab

1.25 mg per dose, delivered monthly by intravitreal injection for six months

DRUG

Intravitreal injection of ranibizumab (0.5 mg per dose)

0.5 mg per dose, delivered monthly by intravitreal injection for six months

Sponsors & Collaborators

  • Retina Associates of Florida, P.A.

    collaborator OTHER

  • Illinois Retina Associates

    collaborator OTHER

  • Kresge Eye Institute

    collaborator OTHER

  • Long Island Vitreoretinal Consultants

    collaborator OTHER

  • Mid Atlantic Retina

    collaborator OTHER

  • Retina Associates, Kansas City

    collaborator OTHER

  • Massachusetts Eye and Ear Infirmary

    collaborator OTHER

  • Barnes Retina Institute

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2015-10-31
Completion
2015-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01428388 on ClinicalTrials.gov