GAL-101 Eye Drops for Age-Related Macular Degeneration

(eDREAM Trial)

Overseen By Yaniv Barkana, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Galimedix Therapeutics Inc

Must not be taking: Ophthalmic medications, Hydroxychloroquine

Disqualifiers: Choroidal neovascularization, Laser therapy, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 48 to 96 weeks

110 Participants Needed

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. ^{1 2 3 4 5}

Research Team

Hermann Russ, MD, PhD

Principal Investigator

Galimedix Therapeutics Inc

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.

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

Treatment Details

Interventions

• GAL-101

Trial Overview 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.

Participant Groups

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

Who Is Running the Clinical Trial?

Galimedix Therapeutics Inc

Lead Sponsor

Trials

1

Recruited

110+

Lexitas Pharma Services, Inc.

Industry Sponsor

Trials

2

Recruited

140+

Findings from Research

Anti-VEGF therapy has significantly changed the treatment landscape for neovascular age-related macular degeneration (nAMD), highlighting its efficacy in managing this condition.

Recent phase 3 clinical trials of intravitreal anti-complement factors, such as pegcetacoplan and avacincaptad pegol, have shown promise in reducing the growth of geographic atrophy in dry age-related macular degeneration (dAMD).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of dry age-related macular degeneration: A review. Girgis, S., Lee, LR.[2023]

The current treatment for wet age-related macular degeneration (AMD) involves intravitreal injections of vascular endothelial growth factor (VEGF) inhibitors, which have been shown to be effective in managing this condition.

For dry AMD, the management strategy includes supplementation with oral antioxidants, highlighting a different approach compared to the treatment of wet AMD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recent advances in the management and understanding of macular degeneration. Bahadorani, S., Singer, M.[2019]

The Age-Related Eye Disease Study 2 (AREDS2) found that adding lutein + zeaxanthin or DHA + EPA to the original AREDS formulation did not significantly reduce the risk of progression to advanced age-related macular degeneration (AMD) in a study of 4203 participants over a median follow-up of 5 years.

Eliminating beta carotene from the AREDS formulation was associated with a higher incidence of lung cancer in former smokers, suggesting that lutein + zeaxanthin could be a safer alternative in the formulation.

NCBI (Pubmed)

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]

A survey of 22 eye nutrient products revealed that while over 75% contained the ingredients recommended by the Age-Related Eye Disease Study (AREDS), only two products matched the recommended dosages.

The study does not conclude on the efficacy of these nutritional supplements for preventing age-related macular degeneration (AMD), highlighting the need for ophthalmologists to be informed about these products to better advise their patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Eye nutrient products for age-related macular degeneration: what do they contain? Arora, S., Musadiq, M., Mukherji, S., et al.[2013]

The study developed a thermo-responsive hydrogel (mPEG-PLGA-BOX) that can effectively deliver bevacizumab, an anti-VEGF drug, to inhibit retinal angiogenesis, showing promise for treating wet age-related macular degeneration (Wet AMD).

In animal studies, the hydrogel demonstrated biocompatibility and successfully suppressed new blood vessel growth in the retina without causing toxicity, indicating its potential for extended drug release and reduced need for frequent injections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Thermo-responsive hydrogel as an anti-VEGF drug delivery system to inhibit retinal angiogenesis in Rex rabbits. Hu, CC., Chiu, YC., Chaw, JR., et al.[2020]

References

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

Treatment of dry age-related macular degeneration: A review. [2023]

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

Recent advances in the management and understanding of macular degeneration. [2019]

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]

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

Eye nutrient products for age-related macular degeneration: what do they contain? [2013]

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]