GAL-101 Eye Drops for Age-Related Macular Degeneration

(eDREAM Trial)

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Galimedix Therapeutics Inc

Must not be taking: Ophthalmic medications, Hydroxychloroquine

Disqualifiers: Choroidal neovascularization, Laser therapy, others

Prior Safety Data

Trial Summary

What is the purpose of this trial?

Age-related macular degeneration (AMD) affects millions of elderly patients. When advanced, there is Geographic Atrophy (GA) in the retina. This means that there is an area with a loss of light-sensitive cells, called photoreceptors. That part of the retina can no longer see. Atrophy begins as a small spot in the retina distant from the fovea which is the part of the retina responsible for sharp central vision. The GA grows, and when it reaches the fovea, vision is severely diminished, and details cannot be seen anymore. The purpose of the eDREAM study is to understand if GAL-101 can slow the growth of GA and prevent it from reaching the fovea. GAL-101 is given as eyedrops. eDREAM patients will administer study eyedrops every day. Patients will be assigned by chance (randomly) to receive either eye-drops that contain the new medication, GAL-101, or eyedrops without the active drug (Placebo). Neither patients nor doctors will know which treatment was assigned to each patient until the end of the study.

Will I have to stop taking my current medications?

The trial requires that you stop using any prescription or over-the-counter eye medications at least one month before starting the study and during the study period. Additionally, you cannot use certain medications like hydroxychloroquine or participate in other investigational drug studies within a month before starting the trial.

How does the drug GAL-101 differ from other treatments for age-related macular degeneration?

GAL-101 eye drops are unique because they offer a non-invasive administration route compared to the common intravitreal injections used for other treatments. This could potentially improve patient comfort and compliance.

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Eligibility Criteria

This trial is for people aged 55 or older with a specific type of age-related macular degeneration (AMD) that leads to geographic atrophy (GA), but not directly affecting the central vision area. Participants must be able to read an eye chart and have someone who can help them administer eyedrops if needed. They should not have severe vision loss or other eye conditions that could interfere with the study.

Inclusion Criteria

I am willing and able to sign a consent form.

I am willing and able to follow the study schedule and complete all required tests.

I have a lesion larger than 1.25 mm2.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

2 visits (in-person)

Treatment

Participants receive daily eye drops of GAL-101 or placebo for 12 to 24 months

48 to 96 weeks

Clinic visits at 1, 3, 6, 9, 12 months, then every 3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Participant Groups

The eDREAM study tests whether GAL-101, given as daily eyedrops, can slow down the growth of GA in AMD patients. Participants will randomly receive either GAL-101 drops or placebo drops without knowing which one they are getting until after the study ends.

Group I: GAL-101 ophthalmic solution Experimental Treatment 1 Intervention

Patient will apply daily 2 eye drops of GAL-101 at 5 minutes interval

Group II: Placebo Placebo Group 1 Intervention

Patient will apply daily 2 eye drops ofPlacebo at 5 minutes interval

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Speciality Retina Center, Dr. Shailesh Gupta Deerfield Beach, FL

Who Is Running the Clinical Trial?

Galimedix Therapeutics Inc Lead Sponsor

Lexitas Pharma Services, Inc. Industry Sponsor

References

1. Australia pubmed.ncbi.nlm.nih.gov

Treatment of dry age-related macular degeneration: A review. [2023] Age-related macular degeneration is a global disease with a significant societal impact. The advent of anti-vascular endothelial growth factor therapy (anti-VEGF) has revolutionised the treatment of neovascular age-related macular degeneration (nAMD). Dry age-related macular degeneration (dAMD) is being investigated for possible therapeutic options. The therapeutic categories undergoing clinical trials include complement pathway inhibitors, visual cycle modulators, reduction of toxic byproducts, antioxidative therapy, neuroprotective agents, laser therapy, surgical options, gene therapy, stem cell therapy, and miscellaneous treatments. Two intravitreal anti-complement factors (pegcetacoplan and avacincaptad pegol) have recently shown phase 3 clinical trial evidence of a reduction in the growth of geographic atrophy. In this review, we provide an update on treatment options currently undergoing clinical research trials for the management of dAMD and preventing the progression of Geographic Atrophy (GA).

2. England pubmed.ncbi.nlm.nih.gov

Recent advances in the management and understanding of macular degeneration. [2019] Current management of age-related macular degeneration (AMD) is directed at intravitreal injection of vascular endothelial growth factor (VEGF) inhibitors for the treatment of wet AMD and supplementation with oral antioxidants for the treatment of dry AMD. In this article, we will review recent clinical trials for the treatment of dry and wet AMD.

3. United States pubmed.ncbi.nlm.nih.gov

Lutein + zeaxanthin and omega-3 fatty acids for age-related macular degeneration: the Age-Related Eye Disease Study 2 (AREDS2) randomized clinical trial. [2022] Oral supplementation with the Age-Related Eye Disease Study (AREDS) formulation (antioxidant vitamins C and E, beta carotene, and zinc) has been shown to reduce the risk of progression to advanced age-related macular degeneration (AMD). Observational data suggest that increased dietary intake of lutein + zeaxanthin (carotenoids), omega-3 long-chain polyunsaturated fatty acids (docosahexaenoic acid [DHA] + eicosapentaenoic acid [EPA]), or both might further reduce this risk.

4. England pubmed.ncbi.nlm.nih.gov

Eye nutrient products for age-related macular degeneration: what do they contain? [2013] Patients are increasingly well informed about the availability of antioxidant products and the claims made for their benefits in age-related macular degeneration (AMD). Consequently, their use is becoming widespread. The purpose of this study is to conduct a survey of the commonly encountered products, and to compare their ingredients with the current Age-Related Eye Disease Study (AREDS) recommendations.

5. Netherlands pubmed.ncbi.nlm.nih.gov

Thermo-responsive hydrogel as an anti-VEGF drug delivery system to inhibit retinal angiogenesis in Rex rabbits. [2020] Wet age-related macular degeneration (Wet AMD) has been treated clinically by intravitreal injection of bevacizumab, which is a kind of the anti-VEGF antibody drug. Nevertheless, because of the short half-life and frequent injections, the use of this treatment is limited.