Aflibercept for Age-Related Macular Degeneration

Recruiting at 1 trial location

Age: Any Age

Sex: Any

Trial Phase: Phase 1

Sponsor: Exegenesis Bio

Disqualifiers: Not enrolled in parent study

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

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

12 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the study team or your doctor.

What data supports the effectiveness of the drug Aflibercept for age-related macular degeneration?

Research shows that Aflibercept improves vision and eye health in patients with age-related macular degeneration, even in those who did not respond well to other treatments like ranibizumab or bevacizumab. ^{1 2 3 4 5}

Is aflibercept safe for humans?

Research shows that aflibercept is generally safe for treating eye conditions like age-related macular degeneration and diabetic macular edema, with studies focusing on both short-term and long-term safety. Some studies have looked at safety in real-life settings and found it to be well-tolerated, though, like any treatment, it may have some risks. ^{6 7 8 9 10}

How is the drug aflibercept unique for treating age-related macular degeneration?

Aflibercept is unique because it can be effective for patients who have not responded well to other treatments like ranibizumab. It works by blocking a protein that causes abnormal blood vessel growth in the eye, which is a key problem in age-related macular degeneration. ^{3 11 12 13 14}

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. This study is designed to fulfill the long-term safety monitoring of EXG102-031. Participants that enroll in this long-term follow-up study have been treated with EXG102-031 under the main study (EXG102-031-211).

Eligibility Criteria

This trial is for patients with wet age-related macular degeneration (nAMD) who have previously been treated with EXG102-031 under the main study. It's a long-term follow-up to monitor safety.

Inclusion Criteria

Must be willing and able to comply with all study procedures.

Are willing and able to sign the study written informed consent form

I was part of the EXG102-031-211 study and received EXG102-031 treatment.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Main Study Treatment

Participants received EXG102-031 gene therapy and were monitored for safety and tolerability over 52 weeks

52 weeks

Long-term Follow-up

Participants are monitored for safety and tolerability of EXG102-031 for an additional 36 months, with regular ocular assessments and potential supplemental therapy with aflibercept

36 months

Regular clinic visits

Treatment Details

Interventions

• Aflibercept

Trial Overview The intervention being studied is Aflibercept (2.0 mg), which aims to block abnormal blood vessel growth in the eye, potentially reducing vision leakage and damage in nAMD patients.

Participant Groups

Group I: All participants who completed the main study of EXG102-031 Experimental Treatment 1 Intervention

All subjects who enroll in this LTFU study have received the experimental treatment with EXG102-031 in the main study, however NO experimental therapy is being administered in this study. The intervention with Aflibercept IVT PRN in this study is NOT experimental.

Who Is Running the Clinical Trial?

Exegenesis Bio

Lead Sponsor

Trials

2

Recruited

20+

Findings from Research

In a study of 36 patients with neovascular age-related macular degeneration (AMD), aflibercept treatment resulted in a significant improvement in visual acuity, with a mean gain of nearly 16 letters after an average follow-up of 12 months.

The treatment was safe and effective, with 97.3% of patients maintaining their vision, and a decrease in central macular thickness, indicating a positive impact on the condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The results of aflibercept therapy as a first line treatment of age-related macular degeneration. Unsal, E., Cubuk, MO.[2023]

In a clinical trial involving 46 patients with recalcitrant exudative age-related macular degeneration (AMD), treatment with 2.0 mg aflibercept maintained stable visual acuity, with no patients losing more than 15 letters on the ETDRS scale after 6 months.

Aflibercept treatment resulted in significant anatomical improvements, as evidenced by a reduction in central subfield thickness (CST), while most patients required monthly injections, indicating a high treatment demand.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aflibercept treatment for patients with exudative age-related macular degeneration who were incomplete responders to multiple ranibizumab injections (TURF trial). Wykoff, CC., Brown, DM., Maldonado, ME., et al.[2022]

In a study of 60 patients receiving an average of 8.4 intravitreal injections of ziv-aflibercept over a mean follow-up of 9.2 months, significant improvements in best-corrected visual acuity (BCVA) and reductions in central macular thickness (CMT) were observed, indicating the treatment's efficacy for retinal disease.

The treatment was found to be safe, with no significant increases in intraocular pressure, no progression of lens opacities, and only one case of mild transient iritis, suggesting that repeated injections of ziv-aflibercept are well-tolerated.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term safety and efficacy of ziv-aflibercept in retinal diseases. Mansour, AM., Ashraf, M., Dedhia, CJ., et al.[2022]

In a study of 32 treatment-naïve patients with neovascular age-related macular degeneration (nvAMD), aflibercept significantly improved best-corrected visual acuity after 13 months, with 46.8% of patients gaining at least 15 letters on the ETDRS scale.

Aflibercept treatment also led to a significant reduction in central macular thickness and was well tolerated, with no adverse events reported, indicating its safety and efficacy in a real-life clinical setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aflibercept as First-Line Therapy in Patients with Treatment-Naïve Neovascular Age-Related Macular Degeneration: Prospective Case Series Analysis in Real-Life Clinical Practice. Udaondo, P., Salom, D., García-Delpech, S., et al.[2017]

Intravitreal aflibercept injection (IAI) demonstrated a safety profile comparable to control treatments across various retinal diseases, with no significant differences in rates of ocular and systemic adverse events among over 4000 patients in 10 clinical trials.

IAI was generally well tolerated, showing lower rates of intraocular inflammation and endophthalmitis compared to controls, indicating its efficacy and safety for treating conditions like neovascular age-related macular degeneration and diabetic macular edema.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comprehensive Review of Ocular and Systemic Safety Events with Intravitreal Aflibercept Injection in Randomized Controlled Trials. Kitchens, JW., Do, DV., Boyer, DS., et al.[2022]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

A single-arm, investigator-initiated study of the efficacy, safety, and tolerability of intravitreal aflibercept injection in subjects with exudative age-related macular degeneration previously treated with ranibizumab or bevacizumab (ASSESS study): 12-month analysis. [2022]

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

Visual and anatomical outcomes following intravitreal aflibercept in eyes with recalcitrant neovascular age-related macular degeneration: 12-month results. [2022]

3. India pubmed.ncbi.nlm.nih.gov

The results of aflibercept therapy as a first line treatment of age-related macular degeneration. [2023]

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

Aflibercept in real-life for the treatment of age-related macular degeneration using a treat and extend protocol: The Armada study. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Aflibercept treatment for patients with exudative age-related macular degeneration who were incomplete responders to multiple ranibizumab injections (TURF trial). [2022]

6. England pubmed.ncbi.nlm.nih.gov

Long-term safety and efficacy of ziv-aflibercept in retinal diseases. [2022]

7. India pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Aflibercept Therapy for Diabetic Macular Edema: A Systematic Review and Meta-Analysis. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Aflibercept as First-Line Therapy in Patients with Treatment-Naïve Neovascular Age-Related Macular Degeneration: Prospective Case Series Analysis in Real-Life Clinical Practice. [2017]

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

Comprehensive Review of Ocular and Systemic Safety Events with Intravitreal Aflibercept Injection in Randomized Controlled Trials. [2022]

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

INCIDENCE AND CAUSES OF VISION LOSS DURING AFLIBERCEPT TREATMENT FOR NEOVASCULAR AGE-RELATED MACULAR DEGENERATION: One-Year Follow-up. [2018]

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

Intravitreal aflibercept efficacy in neovascular age-related macular degeneration with suboptimal response to anti-vascular endothelial growth factor-A therapy. [2022]

12. Germany pubmed.ncbi.nlm.nih.gov

Clinical outcomes after switching treatment from intravitreal ranibizumab to aflibercept in neovascular age-related macular degeneration. [2022]

13. Spain pubmed.ncbi.nlm.nih.gov

Outcomes in patients receiving fixed-dosed aflibercept for treatment-naïve neovascular age-related macular degeneration during one year of routine clinical practice. [2021]

14. Japan pubmed.ncbi.nlm.nih.gov

Efficacy of intravitreal aflibercept in Japanese patients with exudative age-related macular degeneration. [2022]