EYP-1901 for Age-Related Macular Degeneration
(wAMD Trial)
Recruiting in Palo Alto (17 mi)
+28 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: EyePoint Pharmaceuticals, Inc.
Must be taking: Anti-VEGF injections
Disqualifiers: Subfoveal fibrosis, atrophy, scarring, others
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Breakthrough Therapy
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.
12345Is 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.
678910What 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.
35101112Eligibility 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.
Trial 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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: EYP-1901 2686 µgExperimental Treatment1 Intervention
EYP-1901
Group II: AfliberceptActive Control1 Intervention
Aflibercept is already approved in United States, European Union, United States 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
LUGANO Study SiteDallas, TX
LUGANO Study Site'Aiea, HI
LUGANO Study SiteSpringdale, AR
LUGANO Study SiteGlendale, CA
More Trial Locations
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Who Is Running the Clinical Trial?
EyePoint Pharmaceuticals, Inc.Lead Sponsor
References
HIGH-DOSE HIGH-FREQUENCY AFLIBERCEPT FOR RECALCITRANT NEOVASCULAR AGE-RELATED MACULAR DEGENERATION. [2019]To determine the efficacy of monthly (0.1 mL/4 mg) aflibercept for refractory neovascular age-related macular degeneration (wet age-related macular degeneration).
ONE-YEAR FOLLOW-UP OUTCOMES OF TREATMENT OF WET AGE-RELATED MACULAR DEGENERATION WITH AFLIBERCEPT. [2019]To evaluate one-year follow-up outcomes of treatment with aflibercept in patients with newly diagnosed wet age-related macular degeneration (ARMD).
Intravitreal aflibercept (A-IVI) for the treatment of neovascular age-related macular degeneration (nv-AMD): one year experience. [2019]To report the anatomical and functional results of intravitreal injections of aflibercept (Eylea) (A-IVI) for the treatment of naïve eyes with neovascular age-related macular degeneration (nv-AMD).
Evaluation of contrast sensitivity and other visual function outcomes in neovascular age-related macular degeneration patients after treatment switch to aflibercept from ranibizumab. [2022]Label="PURPOSE" NlmCategory="OBJECTIVE">This study evaluated visual function and anatomic and vision-related quality-of-life outcomes in recalcitrant neovascular age-related macular degeneration (AMD) subjects switched to aflibercept (Eylea®) from ranibizumab (Lucentis®).
The results of aflibercept therapy as a first line treatment of age-related macular degeneration. [2023]To report the results of aflibercept treatment in treatment-naive neovascular age-related macular degeneration (AMD) patients and suggest a suitable treatment algorithm for routine clinical practice.
SHORT-TERM SAFETY PROFILE OF INTRAVITREAL ZIV-AFLIBERCEPT. [2022]To evaluate the safety of intravitreal ziv-aflibercept (Zaltrap) in the treatment choroidal neovascularization secondary to age-related macular degeneration.
Vision-Related Quality of Life in Patients with Diabetic Macular Edema Treated with Intravitreal Aflibercept: The AQUA Study. [2020]To examine vision-related quality of life in patients with diabetic macular edema (DME) treated with intravitreal aflibercept (EYLEA, Regeneron Pharmaceuticals, Inc, Tarrytown, NY).
Intravitreal Ziv-Aflibercept for Diabetic Macular Edema: 48-Week Outcomes. [2019]To study the safety and efficacy of intravitreal injections of ziv-aflibercept (IVI-ZA) (Zaltrap; Sanofi-Aventis and Regeneron Pharmaceuticals, Tarrytown, NY) during a period of 48 weeks in patients with diabetic macular edema (DME).
Safety and Efficacy of Ziv-Aflibercept in the Treatment of Refractory Diabetic Macular Edema. [2022]To evaluate the safety and efficacy of ziv-aflibercept (Zaltrap; Sanofi-Aventis, Bridgewater, NJ/Regeneron Pharmaceuticals, Tarrytown, NY) in the treatment of refractory diabetic macular edema (DME).
Aflibercept: A Review of Its Use in Diabetic Macular Oedema. [2022]Aflibercept (Eylea(®)) is an anti-vascular endothelial growth factor agent indicated for intravitreal use in the treatment of diabetic macular oedema. In patients with diabetic macular oedema, significantly greater improvements from baseline to week 52 in visual acuity were seen with intravitreal aflibercept versus macular laser photocoagulation in the phase III VISTA-DME and VIVID-DME trials, and versus intravitreal bevacizumab or ranibizumab in those with worse visual acuity at baseline (i.e. Early Treatment Diabetic Retinopathy Study letter score of
[Preliminary results of treatment with aflibercept]. [2015]The paper presents the first results concerning the Aflibercept (Eylea) treatment, the last antiVEGF approved for treatment of the age related macular degeneration (AMD), neovascular form and for macular edema due to the central retinal vein occlusion. The treatment was applied to patients presenting AMD, ME and other diseases: myopic and idiopatic choroidal neovascularisation, central serous choroidopathy (CSC) or diabetic macular edema (DME). The results were good: improvement of the visual acuity, resolution of the intraretinal fluids and macular edema. Although we did not notice major side-effects, resistance or tachyphylaxis, we noticed some recurrences.
Aflibercept. [2022]In November 2011, aflibercept (Eylea; Regeneron Pharmaceuticals), a recombinant fusion protein that binds to members of the vascular endothelial growth factor family, was approved by the US Food and Drug Administration (FDA) for the treatment of patients with neovascular age-related macular degeneration.