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

Neovascular Age-related Macular Degeneration Clinical Trial

Official title: A Phase I/II, Single-center, Randomized Double Masked Placebo Controlled Study to Evaluate the Safety and Efficacy of Treatment With AS101 1% Oral Solution in Patients With Neovascular Age-Related Macular Degeneration (AMD)

Status Completed

Clinical Trial 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;

Clinical Trial Description

A Phase I/II, single-center, randomized double masked placebo controlled study to evaluate the safety and efficacy of AS101 1% oral solution or placebo once daily for 24 weeks in treating patients with neovascular AMD.

Following confirmation of patient eligibility (as detailed in in the inclusion criteria), patients who meet all of the inclusion and exclusion criteria will be enrolled.

On day 1 patients will be randomly allocated to one of the two following study arms in a 1:1 ratio and in a masked manner: (1) AS101 1% oral solution (2) Placebo oral solution. Patients of both study arms will be instructed on how to administer orally the drug at home once daily for 24 weeks. Patients will stop taking the study oral solution at week 24 treatment visit.

In case of existence of fluid in macula, determined as intra retinal or sub-retinal fluid in the macula (as required in inclusion criteria) the standard to care anti-VEGF intravitreal therapy (Lucentis or Avastin, same as the treatment prior to study start) will be injected by a pro re nata (PRN).

Every 4 weeks the investigator will assess if a patient has a fluid free macula based on clinical evaluation, OCT and FA findings In case of fluid in macula the standard of care anti intravitreal anti VEGF injections (Lucentis or Avastin, same as the treatment prior to study start) will be given the same day by a pro re nata (PRN).

The investigator will monitor the occurrence of any adverse event. The study will be completed at week 24 and the study drug, 1% AS101 oral solution or placebo, will be collected from patients.

At week 28 (4 weeks after treatment completion) all patients will be invited for safety assessment.

If the investigator determines that there is a disease progression study therapy is to be discontinued prior to 24 weeks of treatment. Last observation carried forward (LOCF) technique will be used to analyze such patients.

Efficacy will be evaluated in terms of duration of fluid free macula in the AS101 treated group as compared to placebo treated group; ;

Related Conditions & MeSH terms

• Macular Degeneration
• Neovascular Age-related Macular Degeneration
• Wet Macular Degeneration

• NCT number: NCT03216538
• Study type: Interventional
• Source: Feramda
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: October 8, 2018
• Completion date: July 1, 2020