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Safety and Efficacy of AS101 1% Oral Solution in Patients With Neovascular Age-Related Macular Degeneration (AMD)

NCT03216538 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2020-11-04

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety and efficacy of AS101 1% oral solution as compared to placebo in patients with neovascular Age-Related Macular Degeneration (AMD).

AMD Patients who underwent 3 consecutive intravitreal anti VEGF injections and have sub retinal or intraretinal fluid at day 1 of study will be treated orally by AS101 1% solution or placebo once daily for 24 weeks and will be tested for sub retinal or intraretinal fluid every 4 weeks by OCT examination. In case of fluid in macula anti intravitreal anti VEGF injections will be given the same day as needed (PRN). Safety evaluation will be assessed by adverse events related to treatment of 1% AS101 oral solution or placebo. Efficacy will be evaluated in terms of duration of fluid free macula in the AS101 treated group as as compared to placebo treated group;

Conditions

  • Neovascular Age-related Macular Degeneration

Interventions

DRUG

AS101 1% oral solution

0.4 ml daily p.o.

DRUG

Placebo

0.4 ml daily p.o.

Sponsors & Collaborators

  • Feramda

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-08
Primary Completion
2020-05-01
Completion
2020-07-01

Countries

  • Israel

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03216538 on ClinicalTrials.gov