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

Primary Purpose

Retinal Vein Occlusion, Macular Edema

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intravitreal injection of bevacizumab
Intravitreal injection of ranibizumab (0.5 mg per dose)
Sponsored by
Barnes Retina Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Retinal Vein Occlusion focused on measuring macular edema, vein occlusion, bevacizumab, ranibizumab, vascular endothelial growth factor

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • The Retina Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Bevacizumab

Ranibizumab

Arm Description

Outcomes

Primary Outcome Measures

change in central retinal thickness
central thickness is measured using optical coherence tomography (OCT)

Secondary Outcome Measures

change in best-corrected Snellen visual acuity
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
fluorescein angiograms will measure area of peripheral nonperfusion. This will be interpreted by a designated physician at each testing center.

Full Information

First Posted
September 1, 2011
Last Updated
October 26, 2017
Sponsor
Barnes Retina Institute
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
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1. Study Identification

Unique Protocol Identification Number
NCT01428388
Brief Title
Bevacizumab Versus Ranibizumab in Treatment of Macular Edema From Vein Occlusion
Acronym
CRAVE
Official Title
Comparison of Anti-vascular Endothelial Growth Factors Agents in the Treatment of Macular Edema Following Retinal Vein Occlusion
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Barnes Retina Institute
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

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinal Vein Occlusion, Macular Edema
Keywords
macular edema, vein occlusion, bevacizumab, ranibizumab, vascular endothelial growth factor

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Bevacizumab
Arm Type
Active Comparator
Arm Title
Ranibizumab
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Intravitreal injection of bevacizumab
Intervention Description
1.25 mg per dose, delivered monthly by intravitreal injection for six months
Intervention Type
Drug
Intervention Name(s)
Intravitreal injection of ranibizumab (0.5 mg per dose)
Intervention Description
0.5 mg per dose, delivered monthly by intravitreal injection for six months
Primary Outcome Measure Information:
Title
change in central retinal thickness
Description
central thickness is measured using optical coherence tomography (OCT)
Time Frame
six months compared to baseline
Secondary Outcome Measure Information:
Title
change in best-corrected Snellen visual acuity
Description
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.
Time Frame
six months compared to baseline
Title
change in fluorescein angiogram
Description
fluorescein angiograms will measure area of peripheral nonperfusion. This will be interpreted by a designated physician at each testing center.
Time Frame
six months compared to baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
The Retina Institute
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26431300
Citation
Rajagopal R, Shah GK, Blinder KJ, Altaweel M, Eliott D, Wee R, Cooper B, Walia H, Smith BT, Joseph DP. Bevacizumab Versus Ranibizumab in the Treatment of Macular Edema Due to Retinal Vein Occlusion: 6-Month Results of the CRAVE Study. Ophthalmic Surg Lasers Imaging Retina. 2015 Sep;46(8):844-50. doi: 10.3928/23258160-20150909-09.
Results Reference
derived

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Bevacizumab Versus Ranibizumab in Treatment of Macular Edema From Vein Occlusion

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