Phase 2 N=12 Randomized Single-blind Treatment

REtinal Vein OccLUsion Treatment With Scatter Laser Guided by UWFA in combiNAtion With Ranibizumab Study

Macular Edema · Branch Retinal Vein Occlusion

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View on ClinicalTrials.gov: NCT01247220 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2014

Primary outcome: Primary: Visual Acuity — 16.8; 14.5; 19.1; 15.3 letters on ETDRS Visual Acuity Chart

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Ranibizumab (Drug); Peripheral Laser (Procedure)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Retina Associates of Florida, P.A.
Primary completion: May 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Visual Acuity	16.8; 14.5; 19.1; 15.3	—
SECONDARY Number of Ranibizumab Injections	0.06; 2.2	—
SECONDARY Retinal Thickness	207; 241; 282; 281	—

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 vision results. There is a subgroup of patients with peripheral nonperfusion on ultrawidefield angiography that appears to be more dependent on anti-VEGF treatment. In this trial the investigators compare the gold standard of monthly ranibizumab injections with ranibizumab + peripheral scatter laser to the areas of nonperfusion on angiography. Each group will have monthly injections for the first six months, then as needed by either visual acuity decrease or increased retinal thickness for the subsequent six months. The primary outcome is visual acuity. Secondary outcomes are reduction in optical coherence tomography, and number of ranibizumab injections

Eligibility Criteria

Inclusion Criteria

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 Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01247220). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.