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CompletedNCT01428388CRAVEUpdated Oct 27, 2017

Bevacizumab Versus Ranibizumab in Treatment of Macular Edema From Vein Occlusion

An interventional study of Intravitreal injection of bevacizumab and Intravitreal injection of ranibizumab (0.5 mg per dose) in Retinal Vein Occlusion and Macular Edema, sponsored by Barnes Retina Institute. Completed at 1 site in United States. Open to participants aged 50 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-10-27.

Sponsored by Barnes Retina Institute · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
50 Years and older
Sex
All
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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.

02

Conditions studied

  • Retinal Vein Occlusion
  • Macular Edema

Keywords

  • macular edema
  • vein occlusion
  • bevacizumab
  • ranibizumab
  • vascular endothelial growth factor
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In context

Macular Edema

841 studies on the registry are indexed under Macular Edema; 56 are open to participants now.

This study's planned enrollment of 150 is above the median of 50 across 619 interventional studies indexed under Macular Edema.

Browse Macular Edema studies →

Lead sponsor

Barnes Retina Institute is the lead sponsor of 11 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
150 participants (estimated)

Study arms

  • Active comparator
    Bevacizumab

    Drug: Intravitreal injection of bevacizumab

  • Active comparator
    Ranibizumab

    Drug: Intravitreal injection of ranibizumab (0.5 mg per dose)

Interventions

  • DrugIntravitreal injection of bevacizumab

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

  • DrugIntravitreal injection of ranibizumab (0.5 mg per dose)

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

06

What researchers measure

Primary outcomes

  1. change in central retinal thickness

    central thickness is measured using optical coherence tomography (OCT)

    Time frame: six months compared to baseline

Secondary outcomes

  1. 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.

    Time frame: six months compared to baseline

  2. change in fluorescein angiogram

    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

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Study locations

1 site
  • The Retina Institute
    Saint Louis, Missouri 63110, United States
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References and documents

Publications

  • 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. PubMed 26431300 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 27, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01428388
Lead 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
Responsible party
Rhonda Weeks (Gaurav Shah, MD, Barnes Retina Institute) — Principal investigator
First posted
Sep 5, 2011
Start date
Sep 2011
Primary completion
Oct 2015
Completion
Dec 2015
Last update
Oct 27, 2017

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.

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