Phase 1b/2a Study of EYC-0305 in Patients With Neovascular Age-related Macular Degeneration (OVERTURE)

July 6, 2026 updated by: Eyconis INC.

Open-Label, Multiple Ascending Dose Phase 1b/2a Study of the Safety and Tolerability of Intravitreal (IVT) EYC-0305 in Patients With Neovascular Age-Related Macular Degeneration

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Beverly Hills, California, United States, 90211
        • Recruiting
        • Beverly Hills, CA
    • North Carolina
      • Wake Forest, North Carolina, United States, 27587
        • Recruiting
        • Wake Forest, NC
    • Pennsylvania
      • Erie, Pennsylvania, United States, 16505
        • Recruiting
        • Erie, PA
    • Texas
      • Bellaire, Texas, United States, 77401
        • Recruiting
        • Bellaire, TX
      • McAllen, Texas, United States, 78503
        • Recruiting
        • McAllen, TX
      • The Woodlands, Texas, United States, 77384
        • Recruiting
        • The Woodlands, TX

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EYC-0305 Dose Level 1
Biological: EYC-0305
Extended-delivery anti-VEGF
Experimental: EYC-0305 Dose Level 2
Biological: EYC-0305
Extended-delivery anti-VEGF
Experimental: EYC-0305 Dose Level 3
Biological: EYC-0305
Extended-delivery anti-VEGF
Experimental: EYC-0305 Dose Level 4
Biological: EYC-0305
Extended-delivery anti-VEGF

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence and severity of ocular treatment-emergent adverse events (TEAEs)
Time Frame: Week 72
Week 72
Incidence and severity of systemic treatment-emergent adverse events (TEAEs)
Time Frame: Week 72
Week 72

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eyconis INC.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 19, 2026

Primary Completion (Estimated)

May 1, 2028

Study Completion (Estimated)

May 1, 2028

Study Registration Dates

First Submitted

May 8, 2026

First Submitted That Met QC Criteria

May 8, 2026

First Posted (Actual)

May 14, 2026

Study Record Updates

Last Update Posted (Actual)

July 7, 2026

Last Update Submitted That Met QC Criteria

July 6, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EYC-0305-2501

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

IPD reported in results publication will be shared

IPD Sharing Time Frame

Following publication of the final study results.

IPD Sharing Access Criteria

IPD will be shared with researchers who provide a methodologically sound proposal.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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