Bevacizumab Versus Ranibizumab in Treatment of Macular Edema From Vein Occlusion

Macular Edema Clinical Trial

— CRAVE  

Official title:

Comparison of Anti-vascular Endothelial Growth Factors Agents in the Treatment of Macular Edema Following Retinal Vein Occlusion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01428388
• Other study ID #: CRAVE1
• Status: Completed
• Phase: N/A
• First received: September 1, 2011
• Last updated: October 26, 2017
• Start date: September 2011
• Est. completion date: December 2015

Study information

• Verified date: October 2017
• Source: Barnes Retina Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: December 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Edema
• Macular Edema
• Retinal Vein Occlusion

Intervention

Drug:
• Intravitreal injection of bevacizumab
1.25 mg per dose, delivered monthly by intravitreal injection for six months
• Intravitreal injection of ranibizumab (0.5 mg per dose)
0.5 mg per dose, delivered monthly by intravitreal injection for six months

Locations

Country	Name	City	State
United States	The Retina Institute	Saint Louis	Missouri

Sponsors (8)

Lead Sponsor	Collaborator
Barnes Retina Institute	Illinois Retina Associates, Kresge Eye Institute, Long Island Vitreoretinal Consultants, Massachusetts Eye and Ear Infirmary, Mid Atlantic Retina, Retina Associates of Florida, P.A., Retina Associates, Kansas City

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in central retinal thickness	central thickness is measured using optical coherence tomography (OCT)	six months compared to baseline
Secondary	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.	six months compared to baseline
Secondary	change in fluorescein angiogram	fluorescein angiograms will measure area of peripheral nonperfusion. This will be interpreted by a designated physician at each testing center.	six months compared to baseline