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

NCT03216538 | Completed Phase 1

• 1 other identifier: AS101 AMD# 1ֹ
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Safety assessed by incidence and severity of treatment emerged ocular and non-ocular adverse events

  as assessed by visual acuity measurement, ophthalmic examinations, vital signs, laboratory tests and adverse events related to 1% AS101 oral solution as compared to placebo.

  28 weeks

Secondary Outcomes (5)

• Duration of fluid free macula in average

  28 weeks

• Duration of fluid free macula

  24 weeks

• Best corrected visual acuity (BCVA)

  24 Weeks

• Central retinal subfield thickness (CRT)

  24 weeks

• Lesion size in the macula

  24 weeks

Study Arms (2)

AS101 1% oral solution

ACTIVE COMPARATOR

Daily dose 0.4 ml administered orally

Drug: AS101 1% oral solution

Placebo

PLACEBO COMPARATOR

Daily dose of 0.4 ml administered orally

Drug: Placebo

Interventions

AS101 1% oral solution DRUG

0.4 ml daily p.o.

AS101 1% oral solution

Placebo DRUG

0.4 ml daily p.o.

Placebo

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is diagnosed with CNV from AMD in one or both eyes and eligible for any anti-VEGF treatment in one or two study eyes.
• Patient is 50 years of age or older.
• Patient underwent at least 3 consecutive Intravitreal anti VEGF injections of the same kind , Ranibizumab (Lucentis) or Bevacizumab (Avastin) in the study eye and have sub retinal or intraretinal fluid at day 1, as found in OCT examination.
• Patient must understand and sign the IRB-approved informed consent document for the study.
• Patient must have BCVA of at least 20/200 in the study eye.
• While unlikely, female patients of childbearing potential must not be pregnant or breast-feeding an must be willing to undergo serum pregnancy tests throughout the study. Postmenopausal women must be amenorrheic for at least 12 months in order not to be considered of child-bearing potential.
• Both female patients of childbearing potential and male patients able to father a child must have (or have a partner who has) an acceptable method of contraception (such as hormonal or condoms) throughout the course of the study and for 4 weeks after the last study medication administration.
• Patient must be willing and able to comply with the study procedures.

You may not qualify if:

• Patient exhibits evidence of retinal angiomatous proliferation in the study eye.
• Patient has retinal-choroidal anastomosis in the study eye.
• Patient has a history of treatment for CNV in the study eye with verteporfin, transpupillary thermotherapy, laser photocoagulation, external beam radiation therapy, or other local treatment (such as submacular surgery).
• Patient has a history of systemic, periocular or intraocular steroid use at any time during the 12 weeks prior to enrollment.
• Patient has a corneal melting, necrotizing keratitis/scleritis, scleritis of an infectious etiology or impending vision loss.
• Patient has a known underlying systemic disease with evidence of a serious or potentially lethal uncontrolled active disease in one or more extraocular organ systems for which a defined effective medical regimen is indicated.
• Patient has active pulmonary tuberculosis or active viral hepatitis.
• Patient has a significant active infection.
• Patient has significant renal or hepatic function impairment greater than mild (grade 2) as per CTCAE v4.0 or hypercholesterolemia uncontrolled by medication and/or diet.
• Pregnant patients or lactating.
• Patient has a history of malignancy within the past two years other than non-melanoma skin cancer.
• Patient has an autoimmune systemic disease requiring immunosuppressive treatment or patient has other medical condition that renders the patient immunocompromised.
• Patient received a live vaccine within past six weeks.
• Patient has significant ocular or periocular inflammation or infection in either eye.
• Patient has the presence of active or inactive toxoplasmosis in the study eye.

Sponsors & Collaborators

• Feramda: lead

Study Sites (1)

Meir MC

Kfar Saba, Israel

Location

MeSH Terms

Interventions

ammonium trichloro(dioxoethylene-O,O'-)tellurate; Solutions

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Patients, caregivers and Investigators will be masked to the nature of the treatment until all patients completed participation in the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 7, 2017
• First Posted: July 13, 2017
• Study Start: October 8, 2018
• Primary Completion: May 1, 2020
• Study Completion: July 1, 2020
• Last Updated: November 4, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)