LUCIA: A Phase 3 randomized, double-masked study comparing the efficacy of EYP-1901 against aflibercept

Phase 3

Recruiting

• Conditions: Wet age-related macular degeneration (wAMD)

• Registration Number: 2024-518030-83-00
• Lead Sponsor: Eyepoint Pharmaceuticals Inc.

Brief Summary

To evaluate the efficacy of EYP-1901 2686 μg intravitreal (IVT) insert on best corrected visual acuity (BCVA) changes compared to aflibercept treatment

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-11-08
• Study First Submitted QC: 2024-11-08
• Study First Posted: 2024-11-12
• Study Start: 2024-11-27
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-02
• Last Update Posted: 2025-07-08
• Primary Completion: 2026-10
• Study Completion: 2027-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Not specified
• Target Recruitment: 143

Inclusion Criteria

Subjects will be considered eligible for participation in the study if inclusion criteria are satisfied: 1. Male or female subjects, ≥50 years of age.

2. Able to understand, and willingness to sign, the informed consent and to provide access to personal health information.

3. Willingness and ability to comply with all scheduled visits, restrictions, and assessments.

4. For women of childbearing potential, or men with female partners of childbearing potential, agreement to the use of an appropriate form of contraception at the Screening Visit and for the duration of the study. For the full list of the inclusion criteria please refer to Protocol section 4.1.

Exclusion Criteria

Subjects who meet any of the following exclusion criteria will be excluded from the study: 1. Ocular Exclusion Criteria for the Study Eye Only

2. Ocular Exclusion Criteria for Either Eye

3. General Exclusion Criteria For the full list of the exclusion criteria please refer to Protocol section 4.2.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The primary endpoint of this study is to find out whether EYP-1901 can produce the same vision benefits as aflibercept over 56 weeks.		The primary endpoint of this study is to find out whether EYP-1901 can produce the same vision benefits as aflibercept over 56 weeks.

Secondary Outcome Measures

Name	Time	Method
The secondary endpoints of the study are to find out: 1. Total number of supplemental injections of aflibercept needed over the 56 weeks of treatment		The secondary endpoints of the study are to find out: 1. Total number of supplemental injections of aflibercept needed over the 56 weeks of treatment
2. Changes in the thickness of the retina (light-sensitive membrane at the back of the eye) from Week 12 through Week 56 of treatment		2. Changes in the thickness of the retina (light-sensitive membrane at the back of the eye) from Week 12 through Week 56 of treatment
3. Number of injections a participant needs up to 96 weeks of treatment		3. Number of injections a participant needs up to 96 weeks of treatment
4. Changes in the retina structure and function over the 96 weeks of treatment		4. Changes in the retina structure and function over the 96 weeks of treatment

Trial Locations

Locations (118)

Associated Retina Consultans; 🇺🇸 Gilbert, Arizona, United States

Associated Retina Consultants - Phoenix; 🇺🇸 Phoenix, Arizona, United States

Phoenix Retina Clinical Trials, LLC; 🇺🇸 Phoenix, Arizona, United States

Retina Macula Institute of Arizona; 🇺🇸 Scottsdale, Arizona, United States

Win Retina; 🇺🇸 Arcadia, California, United States

Doctor Retina, PC; 🇺🇸 Beverly Hills, California, United States

The Retina Partners; 🇺🇸 Encino, California, United States

RCOC Clinical Research Institute Inc.; 🇺🇸 Fullerton, California, United States

Global Research Management, Inc.; 🇺🇸 Glendale, California, United States

Atlantis Eyecare; 🇺🇸 Huntington Beach, California, United States

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