Wet Age Related Macular DegenerationPhase 2NCT07811726
A Phase 2 Study of NT-101 Topical in Patients With Wet AMD
A Phase 2 study testing NT-101 ophthalmic solution in people with Wet Age Related Macular Degeneration, run by NexThera Co., Ltd. at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Wet Age Related Macular Degeneration
- What is being tested?
- NT-101 ophthalmic solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 3 sitesUnited States
- Study dates
- 11 Jun 2026to 31 Mar 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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.
- 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:
Show all 25Show fewer
- 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
- Afqlir (aflibercept): 60-day washout
- Enzeevu (aflibercept-abzv): 60-day washout
- Ahzantive (aflibercept-mrbb): 60-day washout
- Demonstrates 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 × ULN
Show all 32Show fewer
- 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.
- Pregnant or breastfeeding or intending 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, unless otherwise allowed at the discretion of the Investigator.
- 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, unless otherwise allowed at the discretion of the Investigator.
- 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.
- Total lesion size >12 disc areas (30.5 mm2), including blood, scar, and neovascularization, in the study eye as assessed by FA.
- Scar, fibrosis, or atrophy involving the center of the fovea in the study eye, as assessed by FA.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Advanced Retina Institute
Bonita Springs, Florida, 34134
Tsipursky S. Michael, M.D.
- Recruiting
Erie Retina Research
Erie, Pennsylvania, 16505
Almeida RP David, M.D.
- Recruiting
Tulsa Retina Consultants
Tulsa, Oklahoma, 74114
Finley, A. Thomas, M.D.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Multicenter Phase 2 Study to Evaluate the Efficacy and Safety of NT-101 Topical Ophthalmic Solution in Patients With Wet Age-Related Macular Degeneration (AMD)
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.
Read the detailed description
This study will consist of a 4-week screening, 12-week treatment, and 4-week follow-up. After completing screening procedures, approximately 66 eligible 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. Following the baseline visit, all study subjects will return to the clinic for study visit assessments at Weeks 4, 8, and 12. Subjects who discontinue early will complete an early termination visit for safety assessments. A follow-up will occur 4 weeks after the end of the treatment period (the last dose) and will include safety and efficacy assessments.
Clinical assessments include BCVA, slit-lamp examination, intraocular pressure (IOP) measurement, optical coherence tomography (OCT), indirect ophthalmoscopy/dilated fundus examination, fundus photography, and fundus fluorescein angiography (FFA). Adverse events (AEs) will be recorded at all study visits.
- Conditions
- Wet Age Related Macular Degeneration
- Being tested
- NT-101 ophthalmic solution, Placebo
- Keywords
- AMD, wet-AMD, Age related Macular Degeneration
- 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 ophthalmic solutionDrug
Also called Placebo comparator intervention
NT-101 is a topical ophthalmic solution containing pigment epithelium-derived factor (PEDF) 34 and type I atelocollagen
PlaceboDrug
NT-101 without Drug Substance
| Study group | Role | What they receive |
|---|---|---|
| NT-101 High Dose (0.2 mM) | Experimental | Not described Receives: Drug: NT-101 ophthalmic solution |
| Placebo (NT-101 without Drug Substance) | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Early Treatment Diabetic Retinopathy Study (ETDRS) BCVA in the study eye at Week 12 compared to baseline
Measured: Week 12 compared to baseline
Secondary outcomes (5)
Change in ETDRS BCVA letter score
Measured: 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)
Measured: at Weeks 4, 8 and 12 compared to baseline
Change in Macular Volume (MV)
Measured: at Weeks 4, 8 and 12 compared to baseline
Change in IOP (intraocular pressure)
Measured: at Weeks 4, 8 and 12 compared to baseline
Number and severity of Treatment-Emergent Adverse Events
Measured: up to week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2026
- Study start11 Jun 2026
- Primary completion28 Feb 2028 (estimated)
- Study completion31 Mar 2028 (estimated)
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NexThera Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07811726
- Sponsor's protocol ID
- NT101-AMD-002
- Status last verified
- Sep 2026
- First submitted
- 28 Aug 2026
- Last updated
- 16 Sep 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 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Multicenter Phase 2 Study to Evaluate the Efficacy and Safety of NT-101 Topical Ophthalmic Solution in Patients With Wet Age-Related Macular Degeneration (AMD)
- ClinicalTrials.gov ID
- NCT07811726
- Acronym / sponsor ID
- NT101-AMD-002
- Conditions
- Wet Age Related Macular Degeneration
- Keywords
- AMD, wet-AMD, Age related Macular Degeneration
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- NexThera Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 11 Jun 2026 (actual)
- Primary completion
- 28 Feb 2028 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 10 Sep 2026 (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.
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.
Detailed description
This study will consist of a 4-week screening, 12-week treatment, and 4-week follow-up. After completing screening procedures, approximately 66 eligible 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. Following the baseline visit, all study subjects will return to the clinic for study visit assessments at Weeks 4, 8, and 12. Subjects who discontinue early will complete an early termination visit for safety assessments. A follow-up will occur 4 weeks after the end of the treatment period (the last dose) and will include safety and efficacy assessments.
Clinical assessments include BCVA, slit-lamp examination, intraocular pressure (IOP) measurement, optical coherence tomography (OCT), indirect ophthalmoscopy/dilated fundus examination, fundus photography, and fundus fluorescein angiography (FFA). Adverse events (AEs) will be recorded at all study visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| NT-101 High Dose (0.2 mM) | Experimental | Drug: NT-101 ophthalmic solution |
| Placebo (NT-101 without Drug Substance) | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- 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:
- 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:
- Demonstrates 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.
Key exclusion criteria (32 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 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.
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 ophthalmic solutionAlso: Placebo comparator interventionNT-101 is a topical ophthalmic solution containing pigment epithelium-derived factor (PEDF) 34 and type I atelocollagen | Drug | NT-101 High Dose (0.2 mM) |
| PlaceboNT-101 without Drug Substance | Drug | Placebo (NT-101 without Drug Substance) |
Primary outcome
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
5 secondary outcomes
Change in ETDRS BCVA letter score
Time frame: 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)
Time frame: at Weeks 4, 8 and 12 compared to baseline
Change in Macular Volume (MV)
Time frame: at Weeks 4, 8 and 12 compared to baseline
Change in IOP (intraocular pressure)
Time frame: at Weeks 4, 8 and 12 compared to baseline
Number and severity of Treatment-Emergent Adverse Events
Time frame: up to week 16
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NT-101 ophthalmic solution in people with Wet Age Related Macular Degeneration, run by NexThera Co., Ltd. at 3 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 25 inclusion and 32 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: looking for participants now, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Youngwoon Kong, Bachelor's degree (070-4667-5991, yw.kong@nexthera.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). 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 16 Sep 2026.