NCT06704009

Brief Summary

Phase 1/2 Trial NT-101 Topical Ophthalmic Solution in Patients with Wet Age-Related Macular Degeneration (AMD)

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Mar 2025

Geographic Reach
1 country

4 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 18, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 25, 2024

Completed
4 months until next milestone

Study Start

First participant enrolled

March 11, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

April 8, 2026

Status Verified

October 1, 2025

Enrollment Period

9 months

First QC Date

November 18, 2024

Last Update Submit

April 6, 2026

Conditions

Wet Age Related Macular DegenerationWet AMD

Keywords

wet AMDAge related Macular DegenerationEyedrop

Outcome Measures

Primary Outcomes (1)

  • Number and Severity of Treatment-Emergent Adverse Events (TEAEs) up to Week 8

    8 weeks

Secondary Outcomes (3)

  • Change in CST in the Study Eye

    Week 4 compared to baseline

  • Change in ETDRS BCVA Letter Score in the Study Eye

    Week 4 compared to baseline

  • Change in IOP in the Study Eye

    Week 4 compared to baseline

Study Arms (2)

NT-101 Low Dose

EXPERIMENTAL
Drug: NT-101 Low Dose

NT-101 High Dose

EXPERIMENTAL
Drug: NT-101 High Dose

Interventions

NT-101 Low DoseDRUG

Low concentration of NT-101 (0.05 mM)

NT-101 Low Dose
NT-101 High DoseDRUG

High concentration of NT-101 (0.2 mM)

NT-101 High Dose

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject who is male or female ≥ 50 years of age at Screening.
  • Choroidal neovascularization (CNV) lesions secondary to AMD that affected the central subfield in the study eye that meets the following criteria at Screening:
  • Total area of CNV (including both classical and occult) comprising \> 50% of the total lesion area on FA
  • Leakage covering \> 50% of the total lesion area on FA
  • 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.
  • No atrophy or fibrosis involving the center of the fovea.
  • BCVA between 25 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: 90-day washout
  • Vabysmo (faricimab-svoa): 90-day washout
  • Biosimilars
  • +9 more criteria

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 x ULN
  • Prothrombin time (PT) \> 1.5 x ULN
  • Hemoglobin (Hb) \< 10 g/dL (male); Hb \< 9 g/dL (female)
  • Platelets \< 100 x 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 diseases).
  • History of stroke or myocardial infarction within 6 months prior to Screening.
  • Subject who has had major surgery within 3 months prior to Screening.
  • +15 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Elman Retina Group

Rosedale, Maryland, 21237, United States

Location

Duke Eye Center

Durham, North Carolina, 27705, United States

Location

Erie Retina Research

Erie, Pennsylvania, 16505, United States

Location

Texas Retina Associates

Dallas, Texas, 75231, United States

Location

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2024

First Posted

November 25, 2024

Study Start

March 11, 2025

Primary Completion

December 15, 2025

Study Completion

May 1, 2026

Last Updated

April 8, 2026

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations

US(4)