NCT07587515

Brief Summary

This Phase 1b/2a study will primarily investigate the safety and tolerability of EYC-0305 delivered by intravitreal (IVT) injection every 24 weeks in patients with neovascular (wet) age-related macular degeneration (AMD). The pharmacokinetics (PK) and immunogenicity of EYC-0305, and the effect on disease activity and vision will also be evaluated.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
24mo left

Started May 2026

Typical duration for phase_1

Geographic Reach
1 country

5 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress1%
May 2026May 2028

First Submitted

Initial submission to the registry

May 8, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 14, 2026

Completed
5 days until next milestone

Study Start

First participant enrolled

May 19, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2028

Last Updated

May 22, 2026

Status Verified

May 1, 2026

Enrollment Period

2 years

First QC Date

May 8, 2026

Last Update Submit

May 19, 2026

Conditions

Keywords

EYC-0305TransCon aVEGFwet AMDneovascular AMDtreatment naiveEyconisanti-VEGF

Outcome Measures

Primary Outcomes (2)

  • Incidence and severity of ocular treatment-emergent adverse events (TEAEs)

    Week 72

  • Incidence and severity of systemic treatment-emergent adverse events (TEAEs)

    Week 72

Study Arms (4)

EYC-0305 Dose Level 1

EXPERIMENTAL
Biological: EYC-0305

EYC-0305 Dose Level 2

EXPERIMENTAL
Biological: EYC-0305

EYC-0305 Dose Level 3

EXPERIMENTAL
Biological: EYC-0305

EYC-0305 Dose Level 4

EXPERIMENTAL
Biological: EYC-0305

Interventions

EYC-0305BIOLOGICAL

Extended-delivery anti-VEGF

EYC-0305 Dose Level 1EYC-0305 Dose Level 2EYC-0305 Dose Level 3EYC-0305 Dose Level 4

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men or women 50 years and older with neovascular (wet) AMD meeting all study-specified eligibility criteria
  • Willing and able to comply with clinic visits and study-related procedures
  • Provide signed informed consent

You may not qualify if:

  • Known hypersensitivity or known allergy that would preclude study drug administration
  • Inability to obtain ophthalmic imaging, eg, due to media opacity, inadequate pupillary dilation, allergy to fluorescein dye or lack of venous access
  • Uncontrolled diabetes mellitus
  • History of cerebrovascular accident (CVA) or myocardial infarction within 180 days of the Day 1 visit
  • Renal failure, dialysis, or history of renal transplant
  • Concurrent psychiatric or medical condition that in the opinion of the Investigator will interfere with study participation or completion
  • Pregnant or breastfeeding women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Beverly Hills, CA

Beverly Hills, California, 90211, United States

NOT YET RECRUITING

Erie, PA

Erie, Pennsylvania, 16505, United States

RECRUITING

Bellaire, TX

Bellaire, Texas, 77401, United States

NOT YET RECRUITING

McAllen, TX

McAllen, Texas, 78503, United States

RECRUITING

The Woodlands, TX

The Woodlands, Texas, 77384, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Central Study Contacts

Kim Reed, OD, FAAO

CONTACT

Karen Chu, MS

CONTACT

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 8, 2026

First Posted

May 14, 2026

Study Start

May 19, 2026

Primary Completion (Estimated)

May 1, 2028

Study Completion (Estimated)

May 1, 2028

Last Updated

May 22, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will share

IPD reported in results publication will be shared

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Following publication of the final study results.
Access Criteria
IPD will be shared with researchers who provide a methodologically sound proposal.
More information

Locations