A pilot clinical trial to evaluate the efficacy and safety of R:GEN(Selective retina therapy) which induce to reduce drusen in patients with intermediate dry Age-related Macular Degeneratio

Not Applicable

Completed

• Conditions: Diseases of the eye and adnexa

• Registration Number: KCT0003227
• Lead Sponsor: The Catholic University of Korea, Yeouido St. Mary's Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 May 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

(1) age greater than 50 years;
(2) bilateral intermediate AMD corresponding to Age-related eye disease study (AREDS) Category 3 (multiple drusen with at least one druse =125 µm;
(3) best corrected visual acuity (BCVA) of 20/63 or better according to the Early Treatment Diabetic Retinopathy Study (ETDRS) using the logarithm of the minimum angle of resolution (logMAR) chart;

Exclusion Criteria

any presence of choroidal neovascularization (CNV); serous pigment epithelium detachment (PED) on color fundus photography (CFP) and OCT; the presence of any hypofluorescent lesion on fundus autofluorescence (FAF) consistent with geographic atrophy (GA); patients who had undergone intraocular surgery (such as cataract surgery or vitrectomy); and patients who were unable to be treated with laser due to the presence of a cataract or vitreous opacity. Eligibility for the study was determined by three retina specialists based on CFP and OCT findings. FFA was performed to confirm the absence of choroidal neovascularization (CNV) in cases where wet AMD was suspected.

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
drusen volume

Secondary Outcome Measures

Name	Time	Method
best corrective visual acuity;retinal sensitivity