Actively Recruiting

Phase 1
Phase 2
Age: 50Years +
All Genders
ID07587515

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

Led by Eyconis INC. · Updated on 2026-05-22

30

Participants Needed

5

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying EYC-0305, an extended-delivery anti-VEGF biological treatment, in patients aged 50 and older with neovascular (wet) age-related macular degeneration (AMD). The main focus is to assess the safety and tolerability of EYC-0305 when given by intravitreal injection every 24 weeks. The study also evaluates how the drug affects disease activity, vision, and its behavior in the body, including immune response and drug levels. This is an open-label Phase 1b/2a study with multiple increasing dose levels of EYC-0305. Participants will receive injections directly into the eye at set intervals of 24 weeks, with four dose levels being studied. The study does not include a placebo group and does not involve masking or blinding. The treatment period extends to 72 weeks to monitor safety and effects over time. Participants will attend clinic visits for injections and monitoring throughout the study. Researchers will assess the incidence and severity of any eye-related or systemic adverse events up to week 72. Additional tests and imaging may be performed to track disease activity and vision changes. The total study duration allows for ongoing evaluation of safety, drug levels, and immune response under medical supervision.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 50Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Men or women 50 years and older with neovascular (wet) AMD meeting all study eligibility criteria
  • Willing and able to comply with clinic visits and study-related procedures
  • Provide signed informed consent
Not Eligible

You will not qualify if you...

  • Known hypersensitivity or allergy preventing study drug administration
  • Unable to obtain ophthalmic imaging due to media opacity, poor pupil dilation, allergy to fluorescein dye, or lack of venous access
  • Uncontrolled diabetes mellitus
  • History of stroke or heart attack within 180 days before study start
  • Renal failure, dialysis, or history of kidney transplant
  • Psychiatric or medical conditions interfering with study participation
  • Pregnant or breastfeeding women

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 72 weeks

Participants receive intravitreal injections of EYC-0305 at ascending dose levels to assess safety and tolerability.

Multiple visits for dosing and safety assessments throughout treatment

Trial Site Locations

Total: 5 locations

1

Beverly Hills, CA

Beverly Hills, California, United States, 90211

Not Yet Recruiting

2

Erie, PA

Erie, Pennsylvania, United States, 16505

Actively Recruiting

3

Bellaire, TX

Bellaire, Texas, United States, 77401

Not Yet Recruiting

4

McAllen, TX

McAllen, Texas, United States, 78503

Actively Recruiting

5

The Woodlands, TX

The Woodlands, Texas, United States, 77384

Not Yet Recruiting

Loading map...

Research Team

K

Kim Reed, OD, FAAO

K

Karen Chu, MS

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

4

Similar Trials

A Phase 1/2 Dose-Escalation and Randomized, Controlled, Mask...

Neovascular (Wet) Age-Related Macular Degeneration

Actively Recruiting

25 locations

A Prospective, Non-interventional, Multicenter, Long-term Fo...

Neovascular (Wet) Age-related Macular Degeneration

Actively Recruiting

10 locations

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here