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Bevacizumab Versus Ranibizumab in Treatment of Macular Edema From Vein Occlusion (CRAVE)

This study is currently recruiting participants.
Verified February 2012 by Barnes Retina Institute
Sponsor:
Collaborators:
Retina Associates of Florida, P.A.
Illinois Retina Associates
Kresge Eye Institute
Long Island Vitreoretinal Consultants
Mid Atlantic Retina
Retina Associates, Kansas City
Massachusetts Eye and Ear Infirmary
Information provided by (Responsible Party):
Rhonda Weeks, Barnes Retina Institute
ClinicalTrials.gov Identifier:
NCT01428388
First received: September 1, 2011
Last updated: February 9, 2012
Last verified: February 2012
History of Changes
  Purpose

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.


Condition Intervention
Retinal Vein Occlusion
Macular Edema
 Drug: Intravitreal injection of bevacizumab
Drug: Intravitreal injection of ranibizumab (0.5 mg per dose)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Comparison of Anti-vascular Endothelial Growth Factors Agents in the Treatment of Macular Edema Following Retinal Vein Occlusion

Resource links provided by NLM:

MedlinePlus related topics: Edema
U.S. FDA Resources

Further study details as provided by Barnes Retina Institute:

Primary Outcome Measures:
  • change in central retinal thickness [ Time Frame: six months compared to baseline ] [ Designated as safety issue: No ]
    central thickness is measured using optical coherence tomography (OCT)


Secondary Outcome Measures:
  • change in best-corrected Snellen visual acuity [ Time Frame: six months compared to baseline ] [ Designated as safety issue: No ]
    best-corrected Snellen visual acuity (BCVA) is the best visual acuity measured using a standard Snellen eye chart at 20 feet between (1) uncorrected vision, (2) vision with current eyeglasses or (3) pinholed visual acuity.

  • change in fluorescein angiogram [ Time Frame: six months compared to baseline ] [ Designated as safety issue: No ]
    fluorescein angiograms will measure area of peripheral nonperfusion. This will be interpreted by a designated physician at each testing center.


Estimated Enrollment: 150
Study Start Date: September 2011
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Bevacizumab Drug: Intravitreal injection of bevacizumab
1.25 mg per dose, delivered monthly by intravitreal injection for six months
Active Comparator: Ranibizumab Drug: Intravitreal injection of ranibizumab (0.5 mg per dose)
0.5 mg per dose, delivered monthly by intravitreal injection for six months

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Ability to provide informed consent
  • Visual acuity of 20/40 - 20/320 in the study eye (regardless of relative APD)
  • Central foveal thickness (CFT) of > 250 microns as assessed by OCT (see below)
  • Diagnosis of retinal vein occlusion in the past 9 months
  • Age over 50 years

Exclusion Criteria:

  • History of previous intraocular surgery in the study eye, including pars plana vitrectomy (but not including uncomplicated cataract surgery), within 60 days of the screening visit
  • Inability to make study visits
  • Uncontrolled glaucoma in the study eye (defined as intraocular pressure (IOP) ≥ 25 mmHg) despite treatment with two or more topical pharmacological anti-glaucomatous medication)
  • Pregnancy or lactation
  • Evidence of any diabetic retinopathy on exam or history of diabetic macular edema within 12 weeks of study onset
  • Any intravitreal injections within 12 weeks of study onset
  • Prior retinal vein occlusion
  • History of pan-retinal photocoagulation within 3 months of study onset or anticipated within 4 months after study onset
  • History of cerebrovascular event or myocardial infarction within 3 months of study onset
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01428388

Locations
United States, Missouri
The Retina Institute Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Gaurav Shah, MD     314-267-1278        
Sponsors and Collaborators
Barnes Retina Institute
Retina Associates of Florida, P.A.
Illinois Retina Associates
Kresge Eye Institute
Long Island Vitreoretinal Consultants
Mid Atlantic Retina
Retina Associates, Kansas City
Massachusetts Eye and Ear Infirmary
  More Information

No publications provided

Responsible Party: Rhonda Weeks, Gaurav Shah, MD, Barnes Retina Institute
ClinicalTrials.gov Identifier: NCT01428388     History of Changes
Other Study ID Numbers: CRAVE1
Study First Received: September 1, 2011
Last Updated: February 9, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Barnes Retina Institute:
macular edema
vein occlusion
bevacizumab
ranibizumab
vascular endothelial growth factor

Additional relevant MeSH terms:
Edema
Macular Edema
Retinal Vein Occlusion
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
 Mitogens
Endothelial Growth Factors
Bevacizumab
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Growth Substances
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2013