The Purpose of This Study is to Evaluate Efficacy and Safety of NT-101 Eye Drops in Patients With Wet Age-Related Macular Degeneration (AMD)

Conditions

• Wet Age Related Macular Degeneration

Eligibility Criteria

Sex

ALL

Age

50 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• NT-101 ophthalmic solution — DRUG
  NT-101 is a topical ophthalmic solution containing pigment epithelium-derived factor (PEDF) 34 and type I atelocollagen
• Placebo — DRUG
  NT-101 without Drug Substance

Study Details

This phase 2 trial is a randomized, double-blind, placebo-controlled, multicenter study in patients with wet AMD to assess the efficacy and safety of NT-101 topical ophthalmic solution (0.20 mM) administered into the study eye twice daily (BID) for 12 weeks.

Key Dates

First listed

Sep 10, 2026

Start date

Jun 11, 2026

Status verified

Sep 2026

Primary completion

Feb 28, 2028

Completion

Mar 31, 2028

Study Design

Enrollment

66 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: NT-101 High Dose (0.2 mM)
• Placebo Comparator: Placebo (NT-101 without Drug Substance)

Primary Outcome Measure

Change in Early Treatment Diabetic Retinopathy Study (ETDRS) BCVA in the study eye at Week 12 compared to baseline [ Time Frame: Week 12 compared to baseline ]

Central Contacts

• Youngwoon Kong, Bachelor's degree
  070-4667-5991
  [email protected]

Locations (3)

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