Clinical trial NCT06704009: NT-101 Topical Ophthalmic Solution in Patients With Wet AMD
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Wet Age Related Macular Degeneration
Wet AMD
Keywords: wet AMD
Age related Macular Degeneration
Eyedrop
Lead sponsor: NexThera Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: KCRN Research, LLC
First posted: 2024-11-25
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

1. Subject who is male or female ≥ 50 years of age at Screening.
2. 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.
3. BCVA between 25 and 78 letters, inclusive, in the study eye at Screening using ETDRS testing, with BCVA decrement primarily attributable to wet AMD.
4. 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
5. 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.
6. Understands and voluntarily signs an informed consent form.
7. 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).

Exclusion Criteria:

1. 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
2. Other clinically significant abnormal lab values per Investigator's judgement.
3. 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).
4. History of stroke or myocardial infarction within 6 months prior to Screening.
5. Subject who has had major surgery within 3 months prior to Screening.
6. Pregnant or breastfeeding or intended to become pregnant during the study.
7. 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.
8. Treatment with investigational therapy or participation in any other type of interventional trial within 30 days before Screening.
9. Subject who has a history of AMD treatment in the study eye with Beovu® (brolucizumab) or photodynamic therapy.
10. 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.)
11. Media opacities or abnormalities in the study eye that would preclude visualization of the retina.
12. Subject who has a history of retinal detachment or retinal detachment repair surgery in the study eye.
13. Subject who has a history of yttrium aluminum garnet (YAG) capsulotomy performed within 2 months prior to randomization in the study eye.
14. 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.
15. 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.
16. Subject who has a history of vitrectomy in the study eye.
17. 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.
18. 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.
19. 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).
20. Non-study eye with a BCVA worse than 20 letters at Screening using ETDRS testing.

Primary outcomes:
measure: Number and Severity of Treatment-Emergent Adverse Events (TEAEs) up to Week 8
timeFrame: 8 weeks
Secondary outcomes:
measure: Change in CST in the Study Eye
timeFrame: Week 4 compared to baseline
measure: Change in ETDRS BCVA Letter Score in the Study Eye
timeFrame: Week 4 compared to baseline
measure: Change in IOP in the Study Eye
timeFrame: Week 4 compared to baseline
Other outcomes:
Locations:
city: Rosedale
country: United States
facility: Elman Retina Group
state: Maryland
city: Durham
country: United States
facility: Duke Eye Center
state: North Carolina
city: Erie
country: United States
facility: Erie Retina Research
state: Pennsylvania
city: Dallas
country: United States
facility: Texas Retina Associates
state: Texas
Study officials:
References: