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

Purpose

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.

Condition

  • Neovascular (Wet) Age-Related Macular Degeneration

Eligibility

Eligible Ages
Over 50 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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 Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

Erie, PA
Erie, Pennsylvania 16505

McAllen, TX
McAllen, Texas 78503

More Details

Status
Recruiting
Sponsor
Eyconis INC.

Study Contact

Kim Reed, OD, FAAO
1-866-392-6647
info@eyconis.com