Branch Retinal Vein Occlusion Study

Clinical Trials :: Branch Retinal Vein Occlusion Study

Ad Title:

Study Title:

Protocol FVF4165g: A Phase III, Multicenter, Randomized, Sham Injection-Controlled Study of the Efficacy and Safety of Ranibizumab Injection Compared with Sham in Subjects with Macular Edema Secondary to Branch Retinal Vein Occlusion

Protocol Number:

062007-016

Department(s) involved in the Study:

Ophthalmology

Purpose of the Study:

Investigators will evaluate the efficacy of intravitreal injections of Lucentis administered monthly for 6 months in the improvement of visual acuity as measured by the mean change in best corrected visual acuity (BCVA) at 6 months compared with baseline. Also, they will evaluate the safety and tolerability of intravitreal injections of Lucentis administered monthly for 6 months, followed by a 6-month observation period with protocol-specified retreatment criteria. Other study objectives will include an evaluation of the effectiveness of intravitreal injections of Lucentis administered monthly for 6 months with respect to visual acuity outcomes (other than mean change in BCVA score at 6 months compared with baseline), anatomic outcomes, and patient-reported visual function outcomes. They will also evaluate the pharmacokinetics of Lucentis treatment in subjects with Branch Retinal Vein Occlusion (BRVO).

Participant Eligibility:

Please inquire with study coordinator for more information regarding study eligibility criteria.

Disease/Condition Under Study:

Branch Retinal Vein Occlusion (BRVO)

Cancer Related Study:

Study Drug(s):

LUCENTIS (ranibizumab injection)

Study Device(s):

Study Doctor:

Dr. Yuguang He

Location of Study:

Sites	Recruiting at this Site
Aston Ambulatory Care Center	Yes

Contact Phone:

214-645-2015

Email:

Jessica.Janecek-Griffin@UTSouthwestern.edu

Other Information:

Website Keywords:

Ophthalmology

Medical Keywords:

blinding eye condition, Eye disease, Ocular, ophthalmic, ophthalmology, Retinal disease