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

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ClinicalTrials.gov Identifier: NCT01428388
Recruitment Status : Completed
First Posted : September 5, 2011
Last Update Posted : October 27, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief 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.

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

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Comparison of Anti-vascular Endothelial Growth Factors Agents in the Treatment of Macular Edema Following Retinal Vein Occlusion
Study Start Date : September 2011
Primary Completion Date : October 2015
Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. change in central retinal thickness [ Time Frame: six months compared to baseline ]
    central thickness is measured using optical coherence tomography (OCT)


Secondary Outcome Measures :
  1. change in best-corrected Snellen visual acuity [ Time Frame: six months compared to baseline ]
    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.

  2. change in fluorescein angiogram [ Time Frame: six months compared to baseline ]
    fluorescein angiograms will measure area of peripheral nonperfusion. This will be interpreted by a designated physician at each testing center.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01428388


Locations
United States, Missouri
The Retina Institute
Saint Louis, Missouri, United States, 63110
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Rhonda Weeks, Gaurav Shah, MD, Barnes Retina Institute
ClinicalTrials.gov Identifier: NCT01428388     History of Changes
Other Study ID Numbers: CRAVE1
First Posted: September 5, 2011    Key Record Dates
Last Update Posted: October 27, 2017
Last Verified: October 2017

Keywords provided by Rhonda Weeks, 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
Bevacizumab
Ranibizumab
Endothelial Growth Factors
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Immunologic Factors