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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 Degeneration

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 Degeneration

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CRIS
Registry ID
KCT0003227
Enrollment
20
Registered
2018-09-28
Start date
2015-08-07
Completion date
Unknown
Last updated
2019-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Biological/Vaccine, Non-Stem Cell, Procedure/Surgery : After evaluation of test spots at the temporal arcades, SRT laser treatment (wavelength 527 nm, pulse repetition rate 100 Hz, pulse energy ramp

Sponsors

The Catholic University of Korea, Yeouido St. Mary's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
drusen volume

Secondary

MeasureTime frame
best corrective visual acuity;retinal sensitivity

Countries

Korea, Republic of

Contacts

Public ContactYoung Gun Park

The Catholic University of Korea, Yeouido St. Mary's Hospital

cuteyg2000@gmail.com+82-2-3779-1243

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026