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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

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.