Clinical trial NCT01198327: Extended Follow-up of Patients With Macular Edema Due to Retinal Vein Occlusion
Official title: Extended Follow-up of Patients With Macular Edema Due to bRanch rETinal Vein Occlusion (BRVO) or centrAl Retinal veIn occlusioN (CRVO) Previously Treated With Intravitreal Ranibizumab
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Retinal Vein Occlusion
Keywords: RVO
CRVO
BRVO
Horizon
Bravo
Cruise
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: The Macula Foundation, Inc.
name: Genentech, Inc.
First posted: 2010-09-10
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study evaluates long-term safety in patients with macular edema due to Retinal Vein Occlusion (RVO) originally enrolled in the BRAVO \& CRUISE trials and subsequently followed in the HORIZON extension trial.

Detailed description: There is strong evidence that ranibizumab provides benefit in subjects with macular edema due to RVO; however, some subjects required continued injections for years to maintain those benefits. It is likely that such subjects have continued production of VEGF (Vascular Endothelial Growth Factor) from areas of nonperfused retina in the periphery. One strategy is to perform scatter photocoagulation to areas of nonperfusion to reduce continued production of VEGF, but it is important to know if visual benefits are maintained when this is done, because if it is not, it would be better to continue intermittent injections of ranibizumab.

Eligibility criteria: Inclusion Criteria:

* Signed informed consent and authorization of use and disclosure of protected health information
* Age greater than or equal to 18 years
* Completion of 12 months in BRAVO or CRUISE trials, with subsequent follow-up in the HORIZON extension study. Exit from HORIZON should be within 90 days of enrollment

Exclusion Criteria:

* Pregnancy (positive pregnancy test) or lactation
* Premenopausal women not using adequate contraception. The following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an IUD, or contraceptive hormone implant or patch.
* Any condition that the investigator believes would pose a significant hazard to the subject if investigational therapy were initiated.
* Inability to comply with study or follow up procedures
* Participation in another simultaneous medical investigation or trial

Primary outcomes:
measure: Incidence of Serious Adverse Events.
timeFrame: 24 mos
Secondary outcomes:
measure: Mean Changes in Visual Acuity
timeFrame: 24 mos from study baseline
measure: Mean Change in Retinal Thickness
timeFrame: 24 mos from study baseline
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Retina-Vitreous Associates Medical Group
state: California
city: Sacremento
country: United States
facility: Retinal Consultants Medical Group
state: California
city: Augusta,
country: United States
facility: Southeast Retina
state: Georgia
city: Boston
country: United States
facility: Ophthalmic consultants of Boston
state: Massachusetts
city: Teaneck
country: United States
facility: Retina Associates of New Jersey
state: New Jersey
city: Houston
country: United States
facility: Retina Consultants of Houston
state: Texas
Study officials:
affiliation: Johns Hopkins University
name: Peter A Campochiaro, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Campochiaro PA, Hafiz G, Channa R, Shah SM, Nguyen QD, Ying H, Do DV, Zimmer-Galler I, Solomon SD, Sung JU, Syed B. Antagonism of vascular endothelial growth factor for macular edema caused by retinal vein occlusions: two-year outcomes. Ophthalmology. 2010 Dec;117(12):2387-2394.e1-5. doi: 10.1016/j.ophtha.2010.03.060. Epub 2010 Jul 13.
citation: Campochiaro PA, Heier JS, Feiner L, Gray S, Saroj N, Rundle AC, Murahashi WY, Rubio RG; BRAVO Investigators. Ranibizumab for macular edema following branch retinal vein occlusion: six-month primary end point results of a phase III study. Ophthalmology. 2010 Jun;117(6):1102-1112.e1. doi: 10.1016/j.ophtha.2010.02.021. Epub 2010 Apr 15.