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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Eyepoint Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Eye Diseases [C11]

Trial duration

5 Jun 2025 → ongoing

Decision date (initial)

2025-05-16

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

EyePoint Pharmaceuticals, Inc.

External identifiers

EU CT number

2024-518030-83-00

ClinicalTrials.gov

NCT06683742

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

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

Secondary objectives 7

1. 1. To evaluate the efficacy of EYP-1901 IVT insert on injection burden through Week 56
2. 2. To evaluate the efficacy of EYP-1901 IVT insert on retinal thickness fluctuation
3. 3. To evaluate the efficacy of EYP-1901 IVT insert on BCVA
4. 4. To evaluate the need for supplemental injection treatment following administration of EYP-1901 IVT insert
5. 5. To evaluate the efficacy of EYP-1901 IVT insert on retinal function and structure
6. 6. To evaluate the efficacy of EYP-1901 IVT insert on injection burden through Week 96
7. 7. To evaluate the efficacy of EYP-1901 IVT insert on retinal thickness fluctuation

Conditions and MedDRA coding

Wet age-related macular degeneration (wAMD)

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. 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. 2. Able to understand, and willingness to sign, the informed consent and to provide access to personal health information.
3. 3. Willingness and ability to comply with all scheduled visits, restrictions, and assessments.
4. 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 3

1. 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. 2. Ocular Exclusion Criteria for Either Eye
3. 3. General Exclusion Criteria For the full list of the exclusion criteria please refer to Protocol section 4.2.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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 endpoints 4

1. 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. 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. 3. Number of injections a participant needs up to 96 weeks of treatment
4. 4. Changes in the retina structure and function over the 96 weeks of treatment

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Eyepoint Inc.

Sponsor organisation

Eyepoint Inc.

Address

480 Pleasant Street

City

Watertown

Postcode

02472-2463

Country

United States

Scientific contact point

Organisation

Eyepoint Pharmaceuticals Inc.

Contact name

Medical Affairs

Public contact point

Organisation

Eyepoint Pharmaceuticals Inc.

Contact name

Medical Affairs

Third parties 10

Locations

5 EU/EEA countries · 36 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 120 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

4 submissions — initial application plus substantial / non-substantial modifications