EXG102-031 for Wet Age-Related Macular Degeneration

Recruiting at 1 trial location

Overseen By Senior Director, Clinical Development

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Exegenesis Bio

Must be taking: Anti-VEGF

Disqualifiers: Retinal detachment, Glaucoma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

12 Participants Needed

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. ^{1 2 3 4 5}

Research Team

Arshad Khanani, MD

Principal Investigator

Sierra Eye Associates

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.

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

Treatment Details

Interventions

• EXG102-031

Trial Overview 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.

Participant Groups

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:

Who Is Running the Clinical Trial?

Exegenesis Bio

Lead Sponsor

Trials

2

Recruited

20+

Findings from Research

In a study of 655 eyes with wet age-related macular degeneration (AMD) receiving anti-VEGF therapy, visual acuity improvements after 12 months were similar across all groups, regardless of lesion activity level, indicating that persistent lesion activity does not necessarily lead to worse visual outcomes.

The number of injections required increased slightly with more active lesions, but the overall visual improvements remained consistent, suggesting that treatment effectiveness is maintained even in cases of higher lesion activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of persistently active neovascular age-related macular degeneration treated with VEGF inhibitors: observational study data. Barthelmes, D., Walton, R., Campain, AE., et al.[2015]

In a study of 20 patients with wet Age-Related Macular Degeneration treated with 3 intravitreal injections of Bevacizumab (Avastin), 30% of eyes showed improved visual acuity, while 55% remained stable, indicating that while many patients did not experience a change in vision, a significant portion reported improved quality of vision.

The treatment led to favorable changes in foveolar thickness and total macular volume in 66.66% and 77.77% of eyes, respectively, suggesting that Avastin effectively reduces retinal swelling, even if visual acuity does not always improve.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Avastin in age related macular degeneration]. Tălu, S., Demea, S., Demea, H., et al.[2015]

In a study of 57 participants with wet age-related macular degeneration (AMD), those who received dietary supplements as recommended by the AREDS2 showed a trend towards fewer anti-vascular endothelial growth factor injections over 3 years (21.89 vs. 26.00), although this difference was not statistically significant.

No significant differences were found in final visual acuity or central macular thickness between the supplement group and the control group, suggesting that while dietary supplementation may influence treatment frequency, it does not significantly impact overall visual outcomes in this study.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

AREDS2 Supplementation in Patients with Wet Age-Related Macular Degeneration. Siag, N., Moshkovsky, R., Golan, N., et al.[2023]

In a study of 65 patients with newly diagnosed active neovascular age-related macular degeneration, the leakage area significantly increased during the pretreatment period, indicating rapid progression of the condition, but visual acuity did not deteriorate during this time.

Despite the increase in leakage area, there was no correlation between this progression and visual outcomes at 3 months or 1 year, suggesting that short-term changes in leakage may not predict long-term visual prognosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short-term progression of wet AMD and correlation with 1-year treatment results. Munk, M., Kiss, C., Sulzbacher, F., et al.[2012]

In a study of 130 eyes from 115 patients with age-related macular degeneration, those who received annual intravitreal anti-vascular endothelial growth factor injections maintained stable visual acuity over an average follow-up of 11.1 years.

Patients who did not receive at least one injection each year experienced a significant decline in visual acuity, highlighting the importance of continuous treatment for preserving vision in this condition.

NCBI (Pubmed)

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. Starr, MR., Kung, FF., Mejia, CA., et al.[2021]

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]

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

[Avastin in age related macular degeneration]. [2015]

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

AREDS2 Supplementation in Patients with Wet Age-Related Macular Degeneration. [2023]

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

Short-term progression of wet AMD and correlation with 1-year treatment results. [2012]

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]