EYP-1901 vs Aflibercept for Age-Related Macular Degeneration
(wAMD Trial)
Recruiting in Palo Alto (17 mi)
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.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, if you are already receiving anti-VEGF injections for your condition, you may need to continue them as part of the study.
What data supports the effectiveness of the drug Aflibercept for treating age-related macular degeneration?
Research shows that Aflibercept is effective in treating age-related macular degeneration, with studies reporting positive outcomes in visual improvement and reduced need for frequent injections.
12345Is EYP-1901 or Aflibercept safe for humans?
Studies on aflibercept (also known as Eylea or Zaltrap) show it is generally safe for treating eye conditions like age-related macular degeneration and diabetic macular edema, with no major adverse events reported in the short term.
678910How is the drug EYP-1901 (Aflibercept) unique for treating age-related macular degeneration?
EYP-1901 (Aflibercept) is unique because it acts as a decoy receptor for VEGF, a protein that promotes abnormal blood vessel growth in the eye, and it requires fewer injections compared to some other treatments, potentially reducing the treatment burden for patients.
911121314Eligibility Criteria
This trial is for individuals with wet Age-Related Macular Degeneration (wAMD), either new or previously treated. Participants must have a certain level of vision, measured by the ETDRS letter score, and if previously treated, they should have had at least two anti-VEGF injections in the past six months.Inclusion Criteria
I've had at least 2 eye injections for wet AMD in the last 6 months.
My vision in the study eye ranges from 20/32 to 20/200 with correction.
I have been diagnosed with wet AMD in one eye, regardless of prior treatments.
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 for up to 2 years
Additional 48 weeks
Participant Groups
The study compares EYP-1901 to Aflibercept over two years to see which is more effective for wAMD. It's a phase 3 trial where participants are randomly assigned treatments and neither they nor the researchers know who gets which treatment (double-masked).
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:
LUCIA Study SiteHagerstown, MD
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Who Is Running the Clinical Trial?
EyePoint Pharmaceuticals, Inc.Lead Sponsor
References
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.
Neovascular age-related macular degeneration treated with ranibizumab or aflibercept in the same large clinical setting: visual outcome and number of injections. [2022]To study visual outcome and number of annual injections in treatment-naïve patients with neovascular age-related macular degeneration (nAMD) before and after a change in first-line therapy from ranibizumab to aflibercept in a high-volume clinical practice.
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 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).
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.
Long-term safety and efficacy of ziv-aflibercept in retinal diseases. [2022]To investigate the long-term safety of intravitreal ziv-aflibercept in eyes receiving six or more intravitreal injections of ziv-aflibercept, an off-label substitute to the approved aflibercept.
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 injection of ziv-aflibercept in patient with refractory age-related macular degeneration. [2015]The results of a patient with exudative age-related macular degeneration who received an intravitreal injection of ziv-aflibercept (Zaltrap; Sanofi-Aventis, Paris, France) in the right eye are described. A complete ocular examination as well as color fundus photography, optical coherence tomography, fluorescein angiography, microperimetry, full-field electroretinography, and multifocal electroretinography were performed and repeated 1 month later. The patient experienced subjective and objective improvement of visual acuity with a decrease in intraretinal and subretinal fluid. Microperimetric improvement also occurred. Electroretinographic changes were noted from baseline to the 30-day follow-up. No adverse events were observed at any time point. Ziv-aflibercept demonstrated short-term safety and efficacy after intravitreal administration for neovascular macular degeneration.
Aflibercept for Diabetic Macular Edema in Real-Life Practice in GREece: Three-Year Outcomes of the ADMIRE Study. [2023]To evaluate the efficacy and safety of intravitreal aflibercept injections for diabetic macular edema (DME) treatment in a tertiary referral center in Greece.
Aflibercept for intravitreal injection: in neovascular age-related macular degeneration. [2021]Aflibercept is a recombinant human fusion protein that acts as a soluble decoy receptor for vascular endothelial growth factor (VEGF) family members VEGF-A, VEGF-B and placental growth factor, thereby preventing these ligands from binding to, and activating, their cognate receptors. The efficacy of intravitreal aflibercept in the treatment of wet (neovascular) age-related macular degeneration has been compared with that of intravitreal ranibizumab, the current gold standard for this indication, in two pivotal phase III studies of virtually identical design (VIEW 1 and 2). In both trials, the recommended regimen of aflibercept [2 mg every second month (after three initial monthly doses)] was shown to be noninferior to the recommended regimen of ranibizumab (0.5 mg every month) in terms of the primary endpoint of the proportion of patients who maintained their vision after 1 year of treatment; similar results were seen when monthly dosing with aflibercept (0.5 or 2 mg) was compared with ranibizumab. Over a period of 96 weeks in the VIEW studies, patients receiving the recommended regimen of aflibercept during the first year followed by modified quarterly treatment during the second year had a similar visual acuity gain to those receiving the recommended regimen of ranibizumab during first year followed by modified quarterly treatment during the second year, but on average required five fewer injections. Aflibercept was generally well tolerated in the VIEW studies; the ocular and non-ocular adverse event profile of the drug was similar to that of ranibizumab.
FLATTENING OF A TREATMENT-RESISTANT RETINAL PIGMENT EPITHELIAL DETACHMENT AFTER A SINGLE INTRAVITREAL INJECTION OF ZIV-AFLIBERCEPT. [2017]To report flattening of a treatment-resistant retinal pigment epithelial detachment (PED) due to neovascular age-related macular degeneration after a single intravitreal injection of ziv-aflibercept (Zaltrap).
Intravitreal Ziv-Aflibercept: A Comprehensive Review. [2019]Background: Age-related macular degeneration is the leading cause of blindness in adults over the age of 50 in the United States of America. Neovascular age-related macular degeneration (nAMD) is sight-threatening, but can be treated by three currently utilized, intravitreally administered drugs: aflibercept, bevacizumab, and ranibizumab. Ziv-aflibercept is an analogue of aflibercept, containing the same active molecule in a different buffer solution, and its recent availability has prompted numerous pre-clinical and clinical trials addressing its viability for intraocular use, summarized herein. Results: Trial outcomes demonstrate that ziv-aflibercept has a similar safety profile to other indicated drugs with effective maintenance or improvement of best-corrected visual acuity (BCVA) and reduction of retinal fluid or central foveal thickness (CFT). Clinical trials of ziv-aflibercept in other neovascular disorders such as diabetic macular edema (DME) and retinal vein occlusion (RVO) have shown similar results. Conclusion: Further prospective, randomized studies of ziv-aflibercept are needed, particularly in eyes with nAMD.
Intravitreal aflibercept (Eylea(®)): a review of its use in patients with macular oedema secondary to central retinal vein occlusion. [2021]Aflibercept is a fully human, recombinant fusion protein that acts as a soluble decoy receptor for vascular endothelial growth factor (VEGF) family members, including VEGF-A, VEGF-B and placental growth factor (P1GF), thereby inhibiting downstream signalling mediated by these ligands. Aflibercept binds all isoforms of VEGF-A with high affinity, and a markedly higher affinity than that of ranibizumab or bevacizumab. A formulation of aflibercept developed specifically for intravitreal injection (Eylea(®)) is approved for use in several countries for the treatment of patients with macular oedema secondary to central retinal vein occlusion (CRVO). In clinical trials (GALILEO and COPERNICUS) in patients with this condition, intravitreal aflibercept 2 mg every month improved best corrected visual acuity (BCVA), as measured by the proportion of study eyes with a gain of ≥15 Early Treatment Diabetic Retinopathy Study letters from baseline, significantly more than sham injections at week 24 (primary analysis). The significant improvements achieved with intravitreal aflibercept compared with sham in the first 6 months were maintained in the second 6 months with as-needed (prn) dosing and monthly monitoring. Continued prn dosing with a reduced monitoring frequency was associated with decreased improvements. More data are needed to confirm the optimal monitoring frequency for use with prn dosing, subsequent to initial monthly injections, in order to maintain long-term efficacy. Intravitreal aflibercept was generally well tolerated in clinical trials and there is little potential for systemic drug accumulation. Thus, intravitreal aflibercept is an effective and generally well tolerated agent that extends the options available for the treatment of macular oedema secondary to CRVO.