ONL1204 Ophthalmic Solution in Patients With Geographic Atrophy Associated With Age-related Macular Degeneration

March 5, 2024 updated by: ONL Therapeutics

A Phase 1b Multicenter, Randomized, Controlled, Single-dose Study of the Safety and Tolerability of ONL1204 Ophthalmic Solution in Patients With Geographic Atrophy (GA) Associated With Age-related Macular Degeneration (AMD

The purpose of this study is to evaluate the safety and tolerability of intravitreal injection of ONL1204 Ophthalmic Solution in patients with geographic atrophy associated with AMD.

GA associated with AMD is one of the world's leading causes of visual disability. It is a progressive disease with no approved therapy to slow or arrest the process of continual photoreceptor and retinal epithelial (RPE) cell loss. A safe and effective therapy for GA will have vast societal benefits. ONL1204 is being developed for this purpose. ONL1204 is a first-in-class inhibitor of fragment apoptosis stimulator receptor-mediated cell death in development for to reduce rates of vision in patients with GA associated with AMD. ONL1204 has demonstrated protection of multiple retinal cell types in several preclinical models of acute ocular injury and the protection of RPE in AMD models. ONL1204 Ophthalmic Solution is currently in a Phase 1 clinical study in patients with macula-off retinal detachment to evaluate safety and tolerability of a single-dose of ONL1204 Ophthalmic Solution. The study is ongoing and uses the same doses and route of administration as this Phase 1b study in patients with GA.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In this study patients will be enrolled and followed for 24 weeks (natural history phase) at which point they will be randomized to 1 of 2 doses of ONL1204 Ophthalmic Solution or sham. Weeks 24 to 48 make up the Treatment Phase. Patients will be on study for a total of 48 weeks.

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • New South Wales
      • Chatswood, New South Wales, Australia, 2067
        • Chatswood Retina
      • Hurstville, New South Wales, Australia, 2220
        • Retina and Eye Consultants Hurtsville
    • Victoria
      • Glen Iris, Victoria, Australia, 3146
        • Retinology Institute
      • Melbourne, Victoria, Australia, 4101
        • Queensland Eye Institute
      • Melbourne, Victoria, Australia, VIC 3002
        • Center for Eye Rearch Australia
      • St Albans, Victoria, Australia, 3021
        • Sunshine Eye Surgeons
  • New Zealand
      • Christchurch, New Zealand, 8013
        • Southern Eye Specialists
    • Auckland
      • Remuera, Auckland, New Zealand, 1050
        • Eye Institute Limited

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

53 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Males and females, ≥ 55 years old
  • Able to give informed consent and attend study visits
  • Bilateral GA secondary to AMD without choroidal neovascularization in either eye
  • ETDRS BCVA 20/400 (Snellen equivalent) or better in both eyes
  • GA ≥1 disc area (DA) (DA, 2.5 mm2)
  • If GA in study eye is multifocal, at least one focal lesion must have a DA of ≥ 1.25 mm2
  • Entire GA area must be visible within the standard FAF field of view
  • Presence of banded or diffuse hyperautofluoresence adjacent to GA lesion in study eye
  • Female subjects must be:
  • Women of non-childbearing potential, or
  • WOCBP with a negative pregnancy test at screening and willing to use permissible methods of contraception for the duration of the study
  • Males with female partners of childbearing potential must agree to use permissible methods of contraception and agree to refrain from donating sperm for the duration of the study.

Exclusion Criteria:

  • GA in either eye due to causes other than AMD
  • Participation in other ophthalmic clinical trials or use of any other investigational drugs or devices in study eye or systemically for 6 months prior to enrollment, or anticipated participation in other ophthalmic clinical trials or use of any other investigational drugs or devices in study eye or systemically during the study period
  • Intraocular inflammation in the study eye
  • Ocular or periocular infection in the study eye
  • Media opacity that would limit baseline visual acuity or clinical visualization of the retina at baseline
  • Hyperautofluoresence adjacent to GA lesion in study eye that is focal only
  • Previous IVT treatment, history of retinal surgery, or other retinal therapeutic procedures in the study eye
  • Systemic immunosuppression that may interfere with retinal and cytokine expression including but not limited to glucocorticoids (eg, oral prednisone or dexamethasone); antimetabolites (eg, methotrexate, mycophenolate mofetil, and azathioprine); T-cell inhibitors (eg, cyclosporine, tacrolimus, sirolimus); alkylating agents (eg, cyclophosphamide and chlorambucil); and biologic agents (eg, tumor necrosis factor inhibitors, interferons, lymphocyte inhibitors, and interleukin inhibitors)
  • Prior history of systemic use of pentosan polysulfate sodium (trade name Elmiron®)
  • Any ocular or systemic condition that in the opinion of the Investigator makes the subject unsuitable treatment with an investigational agent or that would compromise the safety and efficacy assessments of the trial
  • An unwillingness to elect to either a) use Age-related Eye Disease Study 2 (AREDS2) formula nutraceutical therapy for the duration of the study or b) choose not to use such therapy for the duration of the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment Group A
ONL1204 Ophthalmic solution (dose A) administered by intravitreal injection
Drug: ONL1204 Ophthalmic solution
Liquid formulation administered by intravitreal (IVT) injection
Experimental: Treatment Group B
ONL1204 Ophthalmic solution (dose B) administered by intravitreal injection
Drug: ONL1204 Ophthalmic solution
Liquid formulation administered by intravitreal (IVT) injection
Sham Comparator: Treatment Group C
sham injection without penetrating the eye
Procedure: sham injection
sham injection is done by touching the eye surface with a syringe without a needle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Best Corrected Visual Acuity
Time Frame: up to 48 weeks
ETDRS chart (number of letters read)
up to 48 weeks
Intraocular pressure
Time Frame: up to 48 weeks
Intraocular pressure recorded in mmHg
up to 48 weeks
Slit lamp biomicroscopy
Time Frame: up to 48 weeks
Slit lamp using US FDA clinical grading scale 0-4; 0=normal, 4=very severe changes)
up to 48 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ONL Therapeutics

Investigators

  • Principal Investigator: Robyn Guymer, MD, Center for Eye Research Australia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 8, 2021

Primary Completion (Actual)

February 29, 2024

Study Completion (Actual)

February 29, 2024

Study Registration Dates

First Submitted

November 13, 2020

First Submitted That Met QC Criteria

February 3, 2021

First Posted (Actual)

February 9, 2021

Study Record Updates

Last Update Posted (Estimated)

March 6, 2024

Last Update Submitted That Met QC Criteria

March 5, 2024

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ONL1204-GA-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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