Status:
COMPLETED
REtinal Vein OccLUsion Treatment With Scatter Laser Guided by UWFA in combiNAtion With Ranibizumab Study
Lead Sponsor:
Retina Associates of Florida, P.A.
Conditions:
Macular Edema
Branch Retinal Vein Occlusion
Eligibility:
All Genders
18-90 years
Phase:
PHASE2
Brief Summary
Branch retinal vein occlusion is a leading cause of vision loss. Treatment with ranibizumab (vascular endothelial growth factor (VEGF) inhibitor) on a monthly basis has been associated with improved v...
Detailed Description
SUBJECTS Subject Selection Twenty subjects from a single site in the United States will be enrolled. Eligible subjects will have provided informed consent. (See Appendix A, the study flow chart, for s...
Eligibility Criteria
Inclusion
- Subjects will be eligible if the following criteria are met:
- Ability to provide written informed consent and comply with study assessments for the full duration of the study
- Age \> 18 years
- Disease related considerations:
- Study eye with macular edema secondary to branch retinal vein occlusion characterized by:
- Fovea-involved macular edema of less than 12 months peripheral nonperfusion defined as at least 5 disc areas of contiguous nonperfusion on ultra-widefield fluorescein angiography absence of macular traction on clinical exam, UWFA, and OCT.
- Study eye with best corrected visual acuity between 20/40 (≤ 73 letters on ETDRS chart) and 20/320 (≥ 19 letters on ETDRS chart)
- Other considerations
- Patient able to complete all study visits
Exclusion
- Subjects who meet any of the following criteria will be excluded from this study:
- 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.
- Prior enrollment in the study
- Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
- Participation in another simultaneous medical investigation or trial
- Therapy with intravitreal triamcinolone, pegaptanib, ranibizumab, or bevacizumab within the previous 3 months
- Previous macular or panretinal scatter laser photocoagulation
- Previous pars plana vitrectomy
- Visually-significant significant cataracts as primary reason for vision loss
- Myocardial infarction or cerebrovascular accident within 6 months
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01247220
Start Date
November 1 2010
End Date
May 1 2014
Last Update
October 6 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Retina Associates of Florida, P.A.
Tampa, Florida, United States, 33609