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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04744662
Recruitment Status : Recruiting
First Posted : February 9, 2021
Last Update Posted : August 2, 2021
Sponsor:
Information provided by (Responsible Party):
ONL Therapeutics

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Geographic Atrophy Drug: ONL1204 Ophthalmic solution Procedure: sham injection Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model 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.
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : July 8, 2021
Estimated Primary Completion Date : December 30, 2022
Estimated Study Completion Date : April 1, 2023

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Best Corrected Visual Acuity [ Time Frame: up to 48 weeks ]
    ETDRS chart (number of letters read)

  2. Intraocular pressure [ Time Frame: up to 48 weeks ]
    Intraocular pressure recorded in mmHg

  3. 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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 20/50 to 20/400 (Snellen equivalent) in study eye
  • 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 and lesion borders must be within the OCT imaging scans
  • Presence of banded or diffuse hyperautofluoresence adjacent to GA lesion in study eye
  • ETDRS BCVA 20/100 or better in non-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.
  • Willing and able to give informed consent

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04744662


Contacts
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Contact: Jana van de Goor, Ph.D. 650-303-0094 jvandegoor@onltherapeutics.com

Locations
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Australia, Victoria
Center for Eye Rearch Australia Recruiting
Melbourne, Victoria, Australia, VIC 3002
Contact: Suzie Kasses    61410409604      
Sponsors and Collaborators
ONL Therapeutics
Investigators
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Principal Investigator: Robyn Guymer, MD Center for Eye Research Australia
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Responsible Party: ONL Therapeutics
ClinicalTrials.gov Identifier: NCT04744662    
Other Study ID Numbers: ONL1204-GA-001
First Posted: February 9, 2021    Key Record Dates
Last Update Posted: August 2, 2021
Last Verified: July 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Macular Degeneration
Geographic Atrophy
Atrophy
Retinal Degeneration
Retinal Diseases
Eye Diseases
Pathological Conditions, Anatomical
Ophthalmic Solutions
Pharmaceutical Solutions