GAL-101 Eye Drops for Age-Related Macular Degeneration

(eDREAM Trial)

Recruiting at 11 trial locations

Overseen By Galimedix Inc. c/o Imperial CRS, 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether eye drops containing a new medication, GAL-101, can slow the progression of age-related macular degeneration (AMD) and prevent vision loss. AMD can cause Geographic Atrophy (GA), where areas in the eye have non-functioning cells, severely affecting vision. Participants will use the eye drops daily and may receive either the medication or a placebo (a substance with no active drug) without knowing which one they receive. Individuals with AMD and GA that have not yet affected the sharp vision area of their eye might be suitable for this trial. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

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.

Is there any evidence suggesting that GAL-101 eye drops are likely to be safe for humans?

Research shows that GAL-101 eye drops are safe to use. In earlier studies, patients tolerated GAL-101 well. These studies found that the eye drops quickly and effectively reached the back of the eye without causing serious side effects. Initial tests in humans confirmed that GAL-101 is generally safe. Researchers are now testing this treatment further to determine if it can help slow down age-related macular degeneration (AMD), a condition that affects vision. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for AMD?

Unlike the standard treatments for age-related macular degeneration, which often involve injections into the eye, GAL-101 offers a unique approach as an eye drop. GAL-101 is exciting because it targets the disease in a less invasive way, potentially improving patient comfort and adherence. Additionally, the eye drop format may make it easier for patients to manage their treatment at home, reducing the need for frequent trips to the doctor's office. Researchers are keen to see if GAL-101's novel delivery method can maintain or even enhance the effectiveness compared to current therapies.

What evidence suggests that GAL-101 eye drops might be an effective treatment for age-related macular degeneration?

Research has shown that GAL-101 eye drops might slow down or stop the progression of geographic atrophy (GA) in age-related macular degeneration (AMD). GA occurs when retinal cells responsible for vision begin to die. In this trial, participants will receive either GAL-101 or a placebo to evaluate its effectiveness. The treatment aims to prevent GA from affecting the fovea, crucial for clear central vision. Early studies found GAL-101 to be safe and well-tolerated. The goal is to determine if GAL-101 can slow GA's progression, potentially preserving vision. ^{1 3 5 6 7}

Who Is on the Research Team?

Hermann Russ, MD, PhD

Principal Investigator

Galimedix Therapeutics Inc

Are You a Good Fit for This Trial?

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 have a lesion larger than 1.25 mm2.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06659549

A Phase 2 Efficacy and Safety Study of GAL-101 ... 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.

2. galimedix.com galimedix.com/article/galimedix-therapeutics-initiates-pivotal-phase-2-study-with-gal-101-eye-drops-in-dry-amd/

Galimedix Therapeutics initiates pivotal Phase 2 study with ... Study to assess ability of GAL-101 eye drops in slowing or stopping the growth of geographic atrophy, a severe form of age-related macular ...

3. healio.com healio.com/news/optometry/20241226/galimedix-begins-study-of-gal101-eye-drops-for-dry-amd

Galimedix begins study of GAL-101 eye drops for dry AMD Up to 110 participants will be enrolled in the study, with the primary endpoint being reduction in rate of change of geographic atrophy lesions.

4. clinicaltrialsarena.com clinicaltrialsarena.com/news/galimedix-gal-101-2/

Galimedix concludes Phase I trial of GAL-101, plans ... Galimedix Therapeutics has concluded a Phase I trial of GAL-101, which showed that the therapy is safe and well-tolerated without any ...

5. ophthalmologytimes.com ophthalmologytimes.com/view/galimedix-therapeutics-initiates-edream-phase-2-clinical-trial-in-dry-age-related-macular-degeneration

Galimedix Therapeutics initiates eDREAM phase 2 clinical ... eDREAM trial evaluates GAL-101 eye drops in geographic atrophy, a severe dry AMD form, with up to 110 patients over 12-24 months. · Primary ...

6. firstwordpharma.com firstwordpharma.com/story/4737633

Galimedix Therapeutics Presents Data Showing Safety ... In preclinical data, GAL-101 was shown to reach the retina with a greater than 30-fold therapeutic threshold within 5 minutes of eye drop ...

7. galimedix.com galimedix.com/our-pipeline/

Our Pipeline The results of this study demonstrated an excellent safety and tolerability profile of the GAL-101 eye drops and the Phase 1 study protocol was accepted by FDA ...