EYP-1901 for Age-Related Macular Degeneration

(wAMD Trial)

Recruiting at 110 trial locations

Overseen By Ramiro Ribeiro, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: EyePoint Pharmaceuticals, Inc.

Must be taking: Anti-VEGF injections

Disqualifiers: Subfoveal fibrosis, atrophy, scarring, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

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

Compensation: Varies

Number of Visits: Unknown

Duration: 56 weeks

400 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a phase 3 randomized, double -masked study comparing the efficacy of EYP-1901 against Aflibercept.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop your current medications. However, if you are already receiving certain eye injections for your condition, you may need to continue them as part of the study.

What data supports the effectiveness of the drug EYP-1901 for age-related macular degeneration?

Research shows that aflibercept, a component of EYP-1901, is effective in treating age-related macular degeneration, improving vision and eye health in patients. ^{1 2 3 4 5}

Is EYP-1901 safe for humans?

Research on similar treatments like ziv-aflibercept (Zaltrap) and aflibercept (Eylea) shows they have been used safely in patients with eye conditions like diabetic macular edema and age-related macular degeneration. These studies suggest that the treatment is generally safe for human use. ^{6 7 8 9 10}

What makes the drug EYP-1901 (Aflibercept) unique for treating age-related macular degeneration?

EYP-1901 (Aflibercept) is unique because it is a fusion protein that specifically targets and binds to vascular endothelial growth factors, which are involved in the formation of abnormal blood vessels in the eye, helping to improve vision and reduce fluid in the retina. It is administered through intravitreal injections (injections into the eye), which allows for direct treatment of the affected area. ^{3 5 10 11 12}

Eligibility Criteria

This trial is for individuals with wet Age-Related Macular Degeneration (wAMD). Specific eligibility criteria are not provided, but typically participants would need a diagnosis of wAMD and meet certain health standards.

Inclusion Criteria

I've had at least 2 eye injections for wet AMD in the last 6 months.

BCVA by ETDRS letter score between 78 to 35 letters (approximately 20/32 to 20/200 Snellen equivalent) in the study eye at the Screening Visit and on Baseline (Day 1)

I have been diagnosed with wet AMD in one eye, regardless of prior treatments.

Exclusion Criteria

BCVA using ETDRS charts <20 letters (20/400 Snellen equivalent) in the fellow eye

I have scarring or damage under the center of my retina.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either EYP-1901 or Aflibercept for the treatment of wet AMD

56 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Extension

Participants may continue to receive treatment beyond the primary efficacy determination at Week 56

up to 2 years

Treatment Details

Interventions

• Aflibercept
• EYP-1901

Trial Overview The study compares EYP-1901, a potential new treatment for wAMD, to Aflibercept. It's a phase 3 trial where the effectiveness of both treatments will be masked and evaluated over two years, with primary efficacy determined at week 52.

Participant Groups

Group I: EYP-1901 2686 µg Experimental Treatment 1 Intervention

EYP-1901

Group II: Aflibercept Active Control 1 Intervention

Aflibercept is already approved in United States, European Union for the following indications:

Approved in United States as Eylea for:

• Neovascular (Wet) Age-Related Macular Degeneration (AMD)
• Macular Edema following Retinal Vein Occlusion (RVO)
• Diabetic Macular Edema (DME)
• Diabetic Retinopathy (DR)

Approved in European Union as Eylea for:

• Neovascular (Wet) Age-Related Macular Degeneration (AMD)
• Macular Edema following Retinal Vein Occlusion (RVO)
• Diabetic Macular Edema (DME)
• Diabetic Retinopathy (DR)

Approved in United States as Zaltrap for:

• Metastatic Colorectal Cancer

Who Is Running the Clinical Trial?

EyePoint Pharmaceuticals, Inc.

Lead Sponsor

Trials

19

Recruited

2,700+

Findings from Research

In a study of 28 patients with refractory wet age-related macular degeneration, switching to high-dose aflibercept (4 mg every 4 weeks) led to a dry retina in an average of 3.8 months, demonstrating its efficacy in treating resistant cases.

The treatment resulted in significant reductions in retinal fluid and thickness, with 45% of patients experiencing improved vision, and importantly, no serious adverse events were reported, indicating a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

HIGH-DOSE HIGH-FREQUENCY AFLIBERCEPT FOR RECALCITRANT NEOVASCULAR AGE-RELATED MACULAR DEGENERATION. You, QS., Gaber, R., Meshi, A., et al.[2019]

In a study of 28 patients with newly diagnosed wet age-related macular degeneration (ARMD), treatment with aflibercept showed significant efficacy, with 89.3% of eyes maintaining or improving visual acuity after one year.

The treatment was safe, with no recorded complications, and resulted in a substantial reduction in central retinal thickness, indicating effective management of the condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ONE-YEAR FOLLOW-UP OUTCOMES OF TREATMENT OF WET AGE-RELATED MACULAR DEGENERATION WITH AFLIBERCEPT. Klimešová, YM., Penčák, M., Straňák, Z., et al.[2019]

In a study of 26 patients with neovascular age-related macular degeneration (nv-AMD), intravitreal injections of aflibercept (Eylea) led to a significant improvement in visual acuity over 14 months, with 61.5% of eyes showing improvement and a mean visual acuity change from 0.26 to 0.14 LogMAR (P=0.02).

The treatment also resulted in a significant reduction in central macular thickness from 409μm to 229μm (P<0.02), and no adverse events were reported, indicating that aflibercept is a safe and effective option for treating naïve patients with nv-AMD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intravitreal aflibercept (A-IVI) for the treatment of neovascular age-related macular degeneration (nv-AMD): one year experience. Papavasileiou, E., Zygoura, V., Richardson, T., et al.[2019]

In a study of 40 patients with neovascular age-related macular degeneration who switched from ranibizumab to aflibercept, contrast sensitivity improved significantly from baseline to week 12, indicating enhanced visual function.

The central retinal thickness decreased significantly, suggesting that aflibercept may effectively reduce fluid accumulation in the retina, which is crucial for managing this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of contrast sensitivity and other visual function outcomes in neovascular age-related macular degeneration patients after treatment switch to aflibercept from ranibizumab. Nixon, DR., Flinn, NA.[2022]

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]

A study involving 12 patients showed that a single intravitreal injection of ziv-aflibercept for treating choroidal neovascularization due to age-related macular degeneration was safe, with no serious ocular or systemic adverse events reported after 30 days.

While there was only a slight improvement in best-corrected visual acuity after treatment, the absence of significant side effects suggests that ziv-aflibercept could be a viable low-cost alternative for macular disease therapy, especially in resource-limited settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

SHORT-TERM SAFETY PROFILE OF INTRAVITREAL ZIV-AFLIBERCEPT. Chhablani, J., Narayanan, R., Mathai, A., et al.[2022]

In a study of 553 patients with diabetic macular edema treated with intravitreal aflibercept over 52 weeks, there was a significant improvement in vision-related quality of life, as measured by the NEI VFQ-25 total score, which increased by an average of +6.11 points.

The treatment also led to notable improvements in best-corrected visual acuity (BCVA) and a reduction in central retinal thickness (CRT), while the safety profile was consistent with known effects, with 53.6% of patients experiencing treatment-emergent adverse events, including a low incidence of serious ocular events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vision-Related Quality of Life in Patients with Diabetic Macular Edema Treated with Intravitreal Aflibercept: The AQUA Study. Garweg, JG., Stefanickova, J., Hoyng, C., et al.[2020]

Intravitreal injections of ziv-aflibercept (IVI-ZA) over 48 weeks were found to be safe, with no significant changes in electroretinogram results or any systemic or ocular complications in the seven patients with diabetic macular edema (DME).

The treatment led to a significant improvement in best-corrected visual acuity (BCVA) after the first injection, which was maintained throughout the study, and a notable decrease in central retinal thickness (CRT), indicating its efficacy in managing DME.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intravitreal Ziv-Aflibercept for Diabetic Macular Edema: 48-Week Outcomes. de Andrade, GC., de Oliveira Dias, JR., Maia, A., et al.[2019]

In a study of 26 patients with refractory diabetic macular edema (DME), ziv-aflibercept treatment led to significant improvements in visual acuity and macular thickness after switching from previous anti-VEGF therapies.

No adverse ocular or systemic side effects were reported, indicating that ziv-aflibercept is a safe option for patients who did not respond to other treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of Ziv-Aflibercept in the Treatment of Refractory Diabetic Macular Edema. Ashraf, M., Kayal, HE., Souka, AAR.[2022]

Intravitreal aflibercept significantly improved visual acuity in patients with diabetic macular oedema compared to macular laser photocoagulation and other treatments like bevacizumab and ranibizumab, particularly in those with worse baseline vision, as shown in phase III trials.

Aflibercept was generally well tolerated, making it a promising and effective new treatment option for diabetic macular oedema.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aflibercept: A Review of Its Use in Diabetic Macular Oedema. Keating, GM.[2022]

Aflibercept (Eylea) treatment showed positive results in improving visual acuity and resolving macular edema in patients with age-related macular degeneration and other retinal diseases.

The treatment was generally safe, with no major side effects or resistance observed, although some patients experienced recurrences of their conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Preliminary results of treatment with aflibercept]. Blăjan, C., Nicula, D., Rusu, I.[2015]

Aflibercept, also known as Eylea, is a recombinant fusion protein that effectively binds to vascular endothelial growth factor (VEGF) family members, which are involved in abnormal blood vessel growth.

In November 2011, aflibercept received FDA approval for treating neovascular age-related macular degeneration, indicating its recognized efficacy and safety for patients with this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aflibercept. Stewart, MW., Grippon, S., Kirkpatrick, P.[2022]

References

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

HIGH-DOSE HIGH-FREQUENCY AFLIBERCEPT FOR RECALCITRANT NEOVASCULAR AGE-RELATED MACULAR DEGENERATION. [2019]

2. Czech Republic pubmed.ncbi.nlm.nih.gov

ONE-YEAR FOLLOW-UP OUTCOMES OF TREATMENT OF WET AGE-RELATED MACULAR DEGENERATION WITH AFLIBERCEPT. [2019]

3. Greece pubmed.ncbi.nlm.nih.gov

Intravitreal aflibercept (A-IVI) for the treatment of neovascular age-related macular degeneration (nv-AMD): one year experience. [2019]

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

Evaluation of contrast sensitivity and other visual function outcomes in neovascular age-related macular degeneration patients after treatment switch to aflibercept from ranibizumab. [2022]

5. India pubmed.ncbi.nlm.nih.gov

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

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

SHORT-TERM SAFETY PROFILE OF INTRAVITREAL ZIV-AFLIBERCEPT. [2022]

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

Vision-Related Quality of Life in Patients with Diabetic Macular Edema Treated with Intravitreal Aflibercept: The AQUA Study. [2020]

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

Intravitreal Ziv-Aflibercept for Diabetic Macular Edema: 48-Week Outcomes. [2019]

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

Safety and Efficacy of Ziv-Aflibercept in the Treatment of Refractory Diabetic Macular Edema. [2022]

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

Aflibercept: A Review of Its Use in Diabetic Macular Oedema. [2022]

11. Romania pubmed.ncbi.nlm.nih.gov

[Preliminary results of treatment with aflibercept]. [2015]

12. England pubmed.ncbi.nlm.nih.gov

Aflibercept. [2022]