NCT01428388

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 1, 2011

Completed
Same day until next milestone

Study Start

First participant enrolled

September 1, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 5, 2011

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

October 27, 2017

Status Verified

October 1, 2017

Enrollment Period

4.1 years

First QC Date

September 1, 2011

Last Update Submit

October 26, 2017

Conditions

Retinal Vein OcclusionMacular Edema

Keywords

macular edemavein occlusionbevacizumabranibizumabvascular endothelial growth factor

Outcome Measures

Primary Outcomes (1)

  • change in central retinal thickness

    central thickness is measured using optical coherence tomography (OCT)

    six months compared to baseline

Secondary Outcomes (2)

  • change in best-corrected Snellen visual acuity

    six months compared to baseline

  • change in fluorescein angiogram

    six months compared to baseline

Study Arms (2)

Bevacizumab

ACTIVE COMPARATOR
Drug: Intravitreal injection of bevacizumab

Ranibizumab

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

Interventions

Intravitreal injection of bevacizumabDRUG

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

Bevacizumab
Intravitreal injection of ranibizumab (0.5 mg per dose)DRUG

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

Ranibizumab

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Retina Institute

St Louis, Missouri, 63110, United States

Location

Related Publications (1)

  • 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.

    PMID: 26431300DERIVED

MeSH Terms

Conditions

Retinal Vein OcclusionMacular Edema

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesVenous ThrombosisThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesMacular DegenerationRetinal Degeneration

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Gaurav Shah, MD

Study Record Dates

First Submitted

September 1, 2011

First Posted

September 5, 2011

Study Start

September 1, 2011

Primary Completion

October 1, 2015

Study Completion

December 1, 2015

Last Updated

October 27, 2017

Record last verified: 2017-10

Locations

US(1)