EYP-1901 for Age-Related Macular Degeneration

(wAMD Trial)

Not currently recruiting at 116 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called EYP-1901 for age-related macular degeneration (AMD), a condition that can cause vision loss. The goal is to determine if EYP-1901 is more effective than Aflibercept (an anti-VEGF injection), a current AMD treatment. Participants should have wet AMD (a more severe form of the disease) and either have received anti-VEGF injections before or be new to treatment. This study holds significance for individuals affected by AMD, as it might provide a more effective option. As a Phase 3 trial, it represents the final step before potential FDA approval, offering participants access to a promising treatment.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Earlier research found EYP-1901 to be safe and well tolerated by patients with wet age-related macular degeneration (wAMD). Over 190 participants in four studies reported no serious side effects, suggesting that EYP-1901 is generally safe. Aflibercept, the comparator in this study, has FDA approval for treating certain eye conditions, indicating its well-established safety for those uses. Both treatments in this trial have demonstrated good safety records, making them promising options for potential participants. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for age-related macular degeneration?

EYP-1901 is unique because it uses a biodegradable implant that gradually releases the medication over time, potentially reducing the need for frequent injections. Unlike standard treatments for age-related macular degeneration that require monthly visits, EYP-1901 aims for longer-lasting effects with fewer administrations. Researchers are excited about its novel mechanism, which combines a sustained-release delivery with a drug designed to inhibit abnormal blood vessel growth in the eye, potentially improving patient outcomes and convenience.

What evidence suggests that this trial's treatments could be effective for age-related macular degeneration?

Studies have shown that Aflibercept, one of the treatments in this trial, effectively treats age-related macular degeneration (AMD) and helps maintain vision. EYP-1901, another treatment option under study for wet AMD, is a new treatment. Early results indicate it is safe, and patients have tolerated it well. Specifically, patients who received EYP-1901 had stable vision after treatment. This trial will further investigate how well EYP-1901 works compared to current treatments like Aflibercept. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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]

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]

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]

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]

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]

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]

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 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]

Citations

1. investors.eyepointpharma.com investors.eyepointpharma.com/news-releases/news-release-details/eyepoint-announces-pivotal-phase-3-program-initiation-duravyutm

EyePoint Announces Pivotal Phase 3 Program Initiation for ... DURAVYU has efficacy data across approximately 140 wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME) patients ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38881599/

Phase I DAVIO Trial: EYP-1901 Bioerodible, Sustained ... EYP-1901 had a favorable safety profile and was well tolerated in previously treated eyes with wAMD. Measures of biologic activity remained relatively stable.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06683742

NCT06683742 | A 2-year Study of EYP-1901 in Subjects ... In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2666914524000630

Phase I DAVIO Trial: EYP-1901 Bioerodible, Sustained- ... EYP-1901 had a favorable safety profile and was well tolerated in previously treated eyes with wAMD. Measures of biologic activity remained relatively stable.

5. investors.eyepointpharma.com investors.eyepointpharma.com/news-releases/news-release-details/eyepoint-completes-enrollment-pivotal-phase-3-trials-duravyutm

EyePoint Completes Enrollment of Pivotal Phase 3 Trials for ... Supported by robust safety and efficacy data to date, DURAVYU is currently being evaluated in two Phase 3 pivotal trials for wet age-related ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04747197?utm_source=trialradar

First in Human Study to Evaluate the Safety and Tolerability ... This may be indicated by a specific age or the following age groups: The age groups are: Child (birth-17); Adult (18-64); Older Adult (65+) ... A measure of all ...

7. clinicaltrialsarena.com clinicaltrialsarena.com/news/eyepoint-duravyu/

Enrolment concludes in EyePoint's Duravyu Phase III ... EyePoint has confirmed that the safety profile of the therapy, assessed in more than 190 subjects across four studies, showed no serious adverse ...