Clinical trial NCT01428388: Bevacizumab Versus Ranibizumab in Treatment of Macular Edema From Vein Occlusion
Official title: Comparison of Anti-vascular Endothelial Growth Factors Agents in the Treatment of Macular Edema Following Retinal Vein Occlusion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Retinal Vein Occlusion
Macular Edema
Keywords: macular edema
vein occlusion
bevacizumab
ranibizumab
vascular endothelial growth factor
Lead sponsor: Barnes Retina Institute
Sponsor class: OTHER
Collaborators: name: Retina Associates of Florida, P.A.
name: Illinois Retina Associates
name: Kresge Eye Institute
name: Long Island Vitreoretinal Consultants
name: Mid Atlantic Retina
name: Retina Associates, Kansas City
name: Massachusetts Eye and Ear Infirmary
First posted: 2011-09-05
Enrollment: 150
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: change in central retinal thickness
timeFrame: six months compared to baseline
Secondary outcomes:
measure: change in best-corrected Snellen visual acuity
timeFrame: six months compared to baseline
measure: change in fluorescein angiogram
timeFrame: six months compared to baseline
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: The Retina Institute
state: Missouri
Study officials:
References:
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.