EYP-1901 for Age-Related Macular Degeneration (wAMD Trial)
Palo Alto (17 mi)Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: EyePoint Pharmaceuticals, Inc.
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.
What safety data is available for EYP-1901 in treating age-related macular degeneration?The safety data for EYP-1901, also known as aflibercept, Eylea, Zaltrap, and DURAVYU, can be inferred from studies on its use in similar conditions. The safety of intravitreal ziv-aflibercept (Zaltrap) has been evaluated for choroidal neovascularization secondary to age-related macular degeneration. Additionally, ziv-aflibercept has been studied for safety and efficacy in diabetic macular edema, with multiple studies indicating its use in this condition. Aflibercept (Eylea) has also been reviewed for its safety and efficacy in diabetic macular edema, showing significant improvements in visual acuity in clinical trials. These studies collectively provide a safety profile for the use of aflibercept in ocular conditions.247912
Is the drug EYP-1901 (Aflibercept) a promising treatment for Age-Related Macular Degeneration?Yes, EYP-1901 (Aflibercept) is a promising treatment for Age-Related Macular Degeneration. It has been approved by the FDA and has shown good results in improving vision and reducing eye problems in patients with this condition.123511
What data supports the idea that EYP-1901 for Age-Related Macular Degeneration is an effective drug?The available research shows that aflibercept, also known as EYP-1901, is effective for treating age-related macular degeneration. Studies report positive outcomes for patients with this condition, including improvements in vision and eye health. For example, one study found that patients who received aflibercept had better visual function after one year. Another study showed that switching to aflibercept from another treatment led to improved vision-related quality of life. These results suggest that aflibercept is a beneficial option for managing age-related macular degeneration.5681011
Do I have to stop my current medications for this trial?The trial protocol does not specify if you need to stop your current medications. However, if you are already receiving anti-VEGF injections, you may need to continue them as part of the study.
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.
Exclusion Criteria
I have scarring or damage under the center of my retina.
Treatment Details
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
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Who is running the clinical trial?
EyePoint Pharmaceuticals, Inc.Lead Sponsor
References
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.
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.
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.
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®).
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).
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).
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).
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).
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.
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).