EXG102-031 for Wet Age-Related Macular Degeneration

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Arshad Khanani, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Exegenesis Bio

Must be taking: Anti-VEGF

Disqualifiers: Retinal detachment, Glaucoma, others

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

In neovascular (wet) age-related macular degeneration (nAMD), the macula, or the part of the eye that provides the clear, detailed central vision, is being affected by abnormal blood vessel growth and leakage. This leakage affects the vision over time and can lead to severe blurriness or blinding. EXG102-031 was made to block the extra vessel formation which would lead to less leakage affecting the vision. Before EXG102-031 can be tested for its efficacy (if it makes vision better), it must be tested to see if it is safely tolerated to confirm it can continue to be studied in more patients with nAMD.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the drug EXG102-031 for treating wet age-related macular degeneration?

Research shows that treatments using anti-vascular endothelial growth factor (anti-VEGF) injections, like those studied in similar drugs, have been effective in stabilizing and improving vision in patients with wet age-related macular degeneration.

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Eligibility Criteria

This trial is for men and women over 50 with wet age-related macular degeneration (nAMD) who've had some response to previous treatments. They must have a certain level of vision clarity in the affected eye, which should be pseudophakic (after cataract surgery). Participants need to understand the study and consent to join. Those with severe scarring, recent eye surgeries, other major eye diseases, or untreated glaucoma can't join.

Inclusion Criteria

I am 50 years old or older.

I have wet AMD with an active lesion in my eye being studied.

An ETDRS BCVA letter scores between 73 and 19 letters in the study eye

Exclusion Criteria

I had eye surgery in the affected eye within the last 3 months.

My eye has scarring or damage in the central vision area.

I currently have an eye infection.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single subretinal injection of EXG102-031 in the study eye

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

52 weeks

Regular visits as per study protocol

Participant Groups

EXG102-031 is being tested for safety in patients with nAMD. The drug aims to block abnormal blood vessel growth in the eye that causes vision loss by leaking fluid into the macula. This phase of testing will determine if it's safe before checking its effectiveness on improving vision.

Group I: EXG102-031 Experimental Treatment 1 Intervention

Each participant will receive a single subretinal injection of EXG102-031 in the study eye. Participants will be enrolled into one of four dosage groups sequentially, and the dose administered will be determined based on which study group the participant is enrolled into.

EXG102-031 is already approved in United States for the following indications:

🇺🇸 Approved in United States as EXG102-031 for:

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Sierra Eye Associates Reno, NV

Erie Retina Research Erie, PA

Who Is Running the Clinical Trial?

Exegenesis Bio Lead Sponsor

References

1. England pubmed.ncbi.nlm.nih.gov

Outcomes of persistently active neovascular age-related macular degeneration treated with VEGF inhibitors: observational study data. [2015] To describe outcomes of eyes with wet age-related macular degeneration (AMD) subdivided by lesion activity in a large multicentre cohort study.

2. Romania pubmed.ncbi.nlm.nih.gov

[Avastin in age related macular degeneration]. [2015] The purpose of the study is to evaluate the preliminary results of the treatment with Bevacizumab (Avastin) in the neovascular (wet) form of Age-Related Macular Degeneration (AMD).

3. Israel pubmed.ncbi.nlm.nih.gov

AREDS2 Supplementation in Patients with Wet Age-Related Macular Degeneration. [2023] In recent years, major progress has been made in treating the wet form of age-related macular degeneration (AMD) with anti-vascular endothelial growth factors, which reportedly stabilize and improve vision.

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

Short-term progression of wet AMD and correlation with 1-year treatment results. [2012] Quantification of short-term progression of active neovascular age-related macular degeneration and correlation with 1-year outcome.

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

TEN-YEAR FOLLOW-UP OF PATIENTS WITH EXUDATIVE AGE-RELATED MACULAR DEGENERATION TREATED WITH INTRAVITREAL ANTI-VASCULAR ENDOTHELIAL GROWTH FACTOR INJECTIONS. [2021] To identify the visual acuity outcomes of patients with age-related macular degeneration treated with intravitreal anti-vascular endothelial growth factor injections over a 10-year period.