A Phase 2 Study of NT-101 Topical in Patients With Wet AMD

NCT07811726 | Recruiting Phase 2 FDA Drug

• 1 other identifier: NT101-AMD-002
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Wet Age Related Macular Degeneration

Keywords

AMD; wet-AMD; Age related Macular Degeneration

Outcome Measures

Primary Outcomes (1)

• Change in Early Treatment Diabetic Retinopathy Study (ETDRS) BCVA in the study eye at Week 12 compared to baseline

  Week 12 compared to baseline

Secondary Outcomes (5)

• Change in ETDRS BCVA letter score

  at Weeks 4, 8 and 12 compared to baseline

• Change in CST in the study eye assessed by spectral-domain optical coherence tomography (SD-OCT)

  at Weeks 4, 8 and 12 compared to baseline

• Change in Macular Volume (MV)

  at Weeks 4, 8 and 12 compared to baseline

• Change in IOP (intraocular pressure)

  at Weeks 4, 8 and 12 compared to baseline

• Number and severity of Treatment-Emergent Adverse Events

  up to week 16

Study Arms (2)

NT-101 High Dose (0.2 mM)

EXPERIMENTAL

Drug: NT-101 ophthalmic solution

Placebo (NT-101 without Drug Substance)

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Placebo DRUG

NT-101 without Drug Substance

Placebo (NT-101 without Drug Substance)

NT-101 ophthalmic solution DRUG

NT-101 is a topical ophthalmic solution containing pigment epithelium-derived factor (PEDF) 34 and type I atelocollagen

Also known as: Placebo comparator intervention

NT-101 High Dose (0.2 mM)

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject who is male or female ≥ 50 years of age at Screening.
• CNV lesions secondary to AMD that affect the central subfield in the study eye that meet the following criteria at Screening:
• CNV lesions affect the fovea, as evidenced by fluorescein angiography in study eye.
• Intraretinal and/or subretinal fluid affecting the central subfield visible on OCT. If fluid is not visible due to previous treatment, earlier documented OCT images showing fluid for diagnosing wet AMD can be reviewed to fulfill this criterion.
• BCVA between 35 and 78 letters, inclusive, in the study eye at Screening using ETDRS testing, with BCVA decrement primarily attributable to wet AMD.
• Either no previous treatment in the study eye with anti-VEGF therapy (treatment naïve) or previously treated study eye with adequate washout from the baseline visit as defined below:
• Lucentis (ranibizumab): 30-day washout
• Avastin (bevacizumab): 30-day washout
• Eylea (aflibercept): 60-day washout
• Eylea (aflibercept) high dose 8mg: 70-day washout
• Vabysmo (faricimab-svoa): 70-day washout
• Biosimilars
• Byooviz (ranibizumab-nuna): 30-day washout
• Cimerli (ranibizumab-eqrn): 30-day washout
• Pavblu (aflibercept-ayyh): 60-day washout

You may not qualify if:

• Subject who has the following illness or abnormal laboratory test values at
• Screening:
• Uncontrolled hypertension (systolic \> 180 mmHg or diastolic \> 100 mmHg) despite optimal medical regimen
• Uncontrolled diabetes (HbA1c \> 12.0%)
• Total bilirubin \> 1.5 × Upper Limit of Normal (ULN)
• Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 2.5 × ULN
• Prothrombin time (PT) \> 1.5 × ULN
• Hemoglobin (Hb) \< 10 g/dL (male); Hb \< 9 g/dL (female)
• Platelets \< 100 × 103 µL
• Estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73m2
• Positive results for Human Immunodeficiency Virus (HIV) or Hepatitis B or C viruses.
• Other clinically significant abnormal lab values per Investigator's judgement.
• Subject who has a medical condition that, in the opinion of the Investigator, would preclude participation in the study (e.g., unstable medical status including psychiatric disorder, cardiovascular disease, poor glycemic control, and significant medical condition including end-stage renal disease and severe liver disease).
• History of stroke or myocardial infarction (MI) within 6 months prior to Screening.
• Subject who has had major surgery within 3 months prior to Screening.

Sponsors & Collaborators

• NexThera Co., Ltd.: lead

Study Sites (3)

Advanced Retina Institute

Bonita Springs, Florida, 34134, United States

RECRUITING

Tulsa Retina Consultants

Tulsa, Oklahoma, 74114, United States

RECRUITING

Erie Retina Research

Erie, Pennsylvania, 16505, United States

RECRUITING

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Central Study Contacts

Youngwoon Kong, Bachelor's degree

CONTACT

070-4667-5991; yw.kong@nexthera.co.kr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: All sponsor personnel
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: subjects will be randomized in a 1:1 ratio to receive 0.20 mM of NT-101 or placebo to be self-administered (or by a caregiver) two drops of NT-101 or placebo into the study eye twice daily for 12 weeks

Study Record Dates

• First Submitted: August 28, 2026
• First Posted: September 10, 2026
• Study Start: June 11, 2026
• Primary Completion (Estimated): February 28, 2028
• Study Completion (Estimated): March 31, 2028
• Last Updated: September 16, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)