Eye drops could replace injections for wet AMD

NCT ID NCT07811726

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 10, 2026 · Last updated Sep 17, 2026 · Updated 3 times

Summary

Researchers are testing a new eye drop called NT-101 in people with wet age-related macular degeneration, a condition where abnormal blood vessels leak fluid into the retina and damage central vision. The trial enrolls 66 adults aged 50 and older who have active leaking vessels under the fovea. Participants receive either NT-101 drops or a placebo twice daily for 12 weeks, and researchers measure changes in vision and retinal fluid to see if the drops are safe and effective.

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, an eye drop solution containing pigment epithelium-derived factor 34 and type I atelocollagen
What this could lead to
If it works, eye drops could offer a needle-free way to treat wet AMD, replacing or reducing the frequent injections into the eye that patients currently need.
What could go wrong
This is a small phase 2 trial with 66 participants, so any benefit seen may not hold up in larger studies. Eye drops may not reach the retina at high enough levels to match injections, and the treatment could cause eye irritation or other side effects.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 66 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2026

Expected to finish

Mar 2028

An estimate. End dates often move.

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

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. 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. 3. BCVA between 35 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: 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 5. 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. 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 × ULN * 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. 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 disease). 4. History of stroke or myocardial infarction (MI) within 6 months prior to Screening. 5. Subject who has had major surgery within 3 months prior to Screening. 6. Pregnant or breastfeeding or intending 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, unless otherwise allowed at the discretion of the Investigator. 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, unless otherwise allowed at the discretion of the Investigator. 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. 21. Total lesion size \>12 disc areas (30.5 mm2), including blood, scar, and neovascularization, in the study eye as assessed by FA. 22. Scar, fibrosis, or atrophy involving the center of the fovea in the study eye, as assessed by FA.

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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.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    3 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Advanced Retina Institute

    RECRUITING

    Bonita Springs, Florida, 34134, United States

  • Erie Retina Research

    RECRUITING

    Erie, Pennsylvania, 16505, United States

  • Tulsa Retina Consultants

    RECRUITING

    Tulsa, Oklahoma, 74114, United States

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