Wet Age Related Macular DegenerationPhase 1/2NCT06704009
NT-101 Topical Ophthalmic Solution in Patients With Wet AMD
A Phase 1/2 study testing NT-101 Low Dose and NT-101 High Dose in people with Wet Age Related Macular Degeneration and Wet AMD, run by NexThera Co., Ltd. at 4 sites in United States.
Trial summary
Phase 1/2 Trial NT-101 Topical Ophthalmic Solution in Patients with Wet Age-Related Macular Degeneration (AMD) Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Wet Age Related Macular Degeneration, Wet AMD
- What is being tested?
- NT-101 Low Dose and NT-101 High Dose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 4 sitesUnited States
- Study dates
- 11 Mar 2025to 6 May 2026
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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).
Who cannot join
- 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
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- 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.
- Subject who has a history of vitrectomy in the study eye.
- Subject who has a history of ocular surgery in the study eye (including cataract extraction, any intraocular surgery, etc.) within 3 months prior to Screening or anticipated within the next 6 months following randomization.
- Subject who has any history of intraocular inflammation in either eye other than what would be expected in the normal post-operative course following prior routine ocular surgery such as cataract surgery.
- Subject who has other retinal pathologies in the study eye that would interfere with vision, such as evidence of diabetic macular edema or diabetic retinopathy (defined as more than one microaneurysm).
- Non-study eye with a BCVA worse than 20 letters at Screening using ETDRS testing.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Texas Retina Associates
Dallas, Texas, 75231
Duke Eye Center
Durham, North Carolina, 27705
Erie Retina Research
Erie, Pennsylvania, 16505
Elman Retina Group
Rosedale, Maryland, 21237
About this study
Official title: A Randomized, Open-Label, Parallel-group, Multicenter Phase 1/2 Study to Evaluate the Safety and Exploratory Efficacy of NT-101 Topical Ophthalmic Solution in Patients With Wet Age-Related Macular Degeneration (AMD)
Phase 1/2 Trial NT-101 Topical Ophthalmic Solution in Patients with Wet Age-Related Macular Degeneration (AMD)
- Conditions
- Wet Age Related Macular Degeneration, Wet AMD
- Being tested
- NT-101 Low Dose, NT-101 High Dose
- Keywords
- wet AMD, Age related Macular Degeneration, Eyedrop
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NT-101 Low DoseDrug
Low concentration of NT-101 (0.05 mM)
NT-101 High DoseDrug
High concentration of NT-101 (0.2 mM)
| Study group | Role | What they receive |
|---|---|---|
| NT-101 Low Dose | Experimental | Not described Receives: Drug: NT-101 Low Dose |
| NT-101 High Dose | Experimental | Not described Receives: Drug: NT-101 High Dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and Severity of Treatment-Emergent Adverse Events (TEAEs) up to Week 8
Measured: 8 weeks
Secondary outcomes (3)
Change in CST in the Study Eye
Measured by: SD-OCT | Unit: Micrometers (µm)
Measured: Week 4 compared to baseline
Change in ETDRS BCVA Letter Score in the Study Eye
Unit: Letter Score
Measured: Week 4 compared to baseline
Change in IOP in the Study Eye
Unit: Millimeters of Mercury (mmHg)
Measured: Week 4 compared to baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2024
- Study start11 Mar 2025
- Primary completion15 Dec 2025
- Study completion6 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wet Age Related Macular DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- NexThera Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- KCRN Research, LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06704009
- Sponsor's protocol ID
- NT101-AMD-001
- Status last verified
- Oct 2025
- First submitted
- 18 Nov 2024
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, Parallel-group, Multicenter Phase 1/2 Study to Evaluate the Safety and Exploratory Efficacy of NT-101 Topical Ophthalmic Solution in Patients With Wet Age-Related Macular Degeneration (AMD)
- ClinicalTrials.gov ID
- NCT06704009
- Acronym / sponsor ID
- NT101-AMD-001
- Conditions
- Wet Age Related Macular Degeneration, Wet AMD
- Keywords
- wet AMD, Age related Macular Degeneration, Eyedrop
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- NexThera Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- KCRN Research, LLC
- Study start
- 11 Mar 2025 (actual)
- Primary completion
- 15 Dec 2025 (actual)
- Study completion
- 6 May 2026 (actual)
- First posted
- 25 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase 1/2 Trial NT-101 Topical Ophthalmic Solution in Patients with Wet Age-Related Macular Degeneration (AMD)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NT-101 Low Dose | Experimental | Drug: NT-101 Low Dose |
| NT-101 High Dose | Experimental | Drug: NT-101 High Dose |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- 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:
- 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 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:
Key exclusion criteria (30 listed)
- Subject who has the following illness or abnormal laboratory test values at
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NT-101 Low DoseLow concentration of NT-101 (0.05 mM) | Drug | NT-101 Low Dose |
| NT-101 High DoseHigh concentration of NT-101 (0.2 mM) | Drug | NT-101 High Dose |
Primary outcome
Number and Severity of Treatment-Emergent Adverse Events (TEAEs) up to Week 8
Time frame: 8 weeks
3 secondary outcomes
Change in CST in the Study Eye
Time frame: Week 4 compared to baseline
Change in ETDRS BCVA Letter Score in the Study Eye
Time frame: Week 4 compared to baseline
Change in IOP in the Study Eye
Time frame: Week 4 compared to baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing NT-101 Low Dose and NT-101 High Dose in people with Wet Age Related Macular Degeneration and Wet AMD, run by NexThera Co., Ltd. at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 24 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number and Severity of Treatment-Emergent Adverse Events (TEAEs) up to Week 8 (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.