Eye drops could replace needles for blinding eye disease?
NCT ID NCT06704009
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase trial tested NT-101 eye drops in 20 people with wet age-related macular degeneration (AMD), a leading cause of vision loss. The study aimed to check safety and see if the drops could reduce fluid buildup and improve vision. Participants received either a low or high dose of the eye drops for 8 weeks.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- NT-101 topical ophthalmic solution (eye drops)
- What this could lead to
- If successful, this could point toward a non-invasive eye drop treatment for wet AMD, potentially reducing the need for frequent eye injections.
- What could go wrong
- This is a very early, small trial (20 people) focused on safety. It is not designed to prove the treatment works, and many early-stage eye drop therapies fail to show benefit in larger studies.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
-
20 people
The number who actually took part.
- Started
-
Mar 2025
- Finished
-
May 2026
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
50 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Wet age related macular degeneration are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Duke Eye Center
Durham, North Carolina, 27705, United States
-
Elman Retina Group
Rosedale, Maryland, 21237, United States
-
Erie Retina Research
Erie, Pennsylvania, 16505, United States
-
Texas Retina Associates
Dallas, Texas, 75231, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- New eye drug goes Head-to-Head with standard treatment for wet AMD
- New eye drug goes Head-to-Head with standard care for wet AMD
- Eye drops could replace injections for wet AMD
- Could eye drops replace injections for a leading cause of blindness?
- Eye injection burden varies by disease, study finds
- New hope for wet AMD patients: a simple pill may drain stubborn eye fluid