NT-101 Topical Ophthalmic Solution in Patients With Wet AMD

Completed · Phase 1/Phase 2

Conditions studied: Wet Age Related Macular Degeneration, Wet AMD

In brief

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

Key facts

Study ID: NCT06704009
Run by: NexThera Co., Ltd.
People needed: 20
Starts: 2025-03-11
Expected to finish: 2026-05-06
Last updated by the study team: 2026-05-19

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

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
Byooviz (ranibizumab-nuna): 30-day washout
Cimerli (ranibizumab-eqrn): 30-day washout
Demonstrate the ability to instill eye drops (by the subject or caregiver) in the study eye, express willingness to comply with the dosing regimen, and commit to attending all study visits.
Understands and voluntarily signs an informed consent form.
Female participants of childbearing potential and male participants able to father children must have (or have a partner who has) had a hysterectomy or vasectomy, be completely abstinent from intercourse, or agree to practice two acceptable methods of contraception throughout the course of the study and 3 months after their last study administration. Acceptable methods of contraception include :
hormonal contraception (i.e., birth control pills, injected hormones, dermal patch, or vaginal ring),
intrauterine device,
barrier methods (diaphragm, condom) with spermicide, or
surgical sterilization (hysterectomy or tubal ligation).

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.
Pregnant or breastfeeding or intended to become pregnant during the study.
Subject with known hypersensitivity to any active substance or excipients of the investigational product, fluorescein, dilating eye drops, or any of the anesthetic and antimicrobial drops.
Treatment with investigational therapy or participation in any other type of interventional trial within 30 days before Screening.
Subject who has a history of AMD treatment in the study eye with Beovu® (brolucizumab) or photodynamic therapy.
CNV in the study eye secondary to other causes or subject who has an ocular condition (other than AMD) that, in the opinion of the Investigator, may limit visual acuity improvement during the course of the study (e.g., ocular histoplasmosis, trauma, pathological myopia, angioid streaks, choroidal rupture, multifocal choroiditis, congenital eye malformations, retinal pigment epithelial tear, or posterior uveitis etc.)
Media opacities or abnormalities in the study eye that would preclude visualization of the retina.
Subject who has a history of retinal detachment or retinal detachment repair surgery in the study eye.
Subject who has a history of yttrium aluminum garnet (YAG) capsulotomy performed within 2 months prior to randomization in the study eye.
Uncontrolled glaucoma in either eye (IOP > 25 mmHg despite treatment with a standard regimen of antiglaucoma medications), with exceptions allowed at the Investigator's discretion.
Any active intraocular or periocular infection or active intraocular inflammation (e.g., infectious conjunctivitis, keratitis, scleritis, endophthalmitis, infectious blepharitis, uveitis) in either eye on Screening.

Where it is running

Elman Retina Group — Rosedale, Maryland, United States
Duke Eye Center — Durham, North Carolina, United States
Erie Retina Research — Erie, Pennsylvania, United States
Texas Retina Associates — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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