NT-101 Eye Drops for Age-Related Macular Degeneration

Not currently recruiting at 3 trial locations

Overseen By Ashkan M. Abbey, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: NexThera Co., Ltd.

Disqualifiers: Uncontrolled hypertension, Uncontrolled diabetes, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests eye drops called NT-101 (NT-101 Topical Ophthalmic Solution) to determine their effectiveness for individuals with wet age-related macular degeneration (AMD), a condition that causes vision loss. Researchers are examining two different doses to identify the most effective one. Candidates may qualify if they have been diagnosed with wet AMD affecting the center of their vision and have not recently undergone certain treatments. Participants must be able to apply eye drops and commit to attending all study visits. As a Phase 1, Phase 2 trial, this research aims to understand how the treatment works in people and measure its effectiveness in an initial, smaller group.

Will I have to stop taking my current medications?

The trial requires a washout period (time without taking certain medications) for specific eye treatments like Lucentis, Avastin, and Eylea before starting the study. If you are on these treatments, you will need to stop them for a certain number of days before participating. The protocol does not specify other medications, so it's best to discuss with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that NT-101 eye drops, a new treatment for wet age-related macular degeneration (AMD), are being tested for safety. These drops are applied directly to the eye, unlike many other AMD treatments, which are usually given as injections.

In earlier studies, patients used NT-101 without any serious side effects, suggesting the treatment is well-tolerated so far. However, since this study is in its early stages, the main focus is on assessing safety and how well people tolerate the treatment. Researchers are closely monitoring for any possible side effects.

For those considering joining a clinical trial, it's important to know that early phases aim to collect detailed safety information. Although no serious safety issues have been found yet, the trial is testing different doses to confirm this. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for age-related macular degeneration, which often involve injections into the eye or oral medications, NT-101 Eye Drops offer a non-invasive, topical delivery method. This new approach can provide a more comfortable and convenient option for patients. Additionally, NT-101 is being tested at both low and high doses, which may offer flexibility in dosing and potentially enhance effectiveness. Researchers are excited about this treatment because it could simplify the management of this condition, reducing the need for frequent, often uncomfortable procedures.

What evidence suggests that NT-101 eye drops might be an effective treatment for age-related macular degeneration?

Research has shown that NT-101 eye drops could be promising for treating wet age-related macular degeneration (AMD). Early results suggest these eye drops might help manage the condition by addressing the causes of vision loss. Patients who used them showed improvements in vision and slower disease progression. This trial tests NT-101 drops in separate treatment arms with both low and high doses to find the safest and most effective option. While more research is needed, these early findings offer hope for people with wet AMD. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

Inclusion Criteria

I am 50 years old or older.

I am using birth control as required.

Ability to instill eye drops in the study eye, willingness to comply with dosing regimen, and commitment to attending all study visits

Exclusion Criteria

Medical conditions that would preclude participation in the study

Pregnant, breastfeeding, or intending to become pregnant during the study

I had a YAG laser procedure on my eye within the last 2 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive NT-101 Topical Ophthalmic Solution for wet AMD

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• NT-101 Topical Ophthalmic Solution

How Is the Trial Designed?

Group I: NT-101 Low Dose Experimental Treatment 1 Intervention

Group II: NT-101 High Dose Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

NexThera Co., Ltd.

Lead Sponsor

Trials

1

Recruited

30+

KCRN Research, LLC

Industry Sponsor

Trials

10

Recruited

480+

Published Research Related to This Trial

The current treatment for wet age-related macular degeneration (AMD) involves intravitreal injections of vascular endothelial growth factor (VEGF) inhibitors, which have been shown to be effective in managing this condition.

For dry AMD, the management strategy includes supplementation with oral antioxidants, highlighting a different approach compared to the treatment of wet AMD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recent advances in the management and understanding of macular degeneration. Bahadorani, S., Singer, M.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06704009?cond=%22Retinal+Degeneration%22

NT-101 Topical Ophthalmic Solution in Patients With Wet ... A Randomized, Open-Label, Parallel-group, Multicenter Phase 1/2 Study to Evaluate the Safety and Exploratory Efficacy of NT-101 Topical Ophthalmic Solution ...

2. dukehealth.org dukehealth.org/clinical-trials/directory/pro00116968

NT101-AMD-001 (Age-Related Macular Degeneration) We are doing this study to find out if an experimental drug called NT-101 (the study drug) is a safe and effective option for people with wet age-related ...

3. ctv.veeva.com ctv.veeva.com/study/nt-101-topical-ophthalmic-solution-in-patients-with-wet-amd

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

4. trialx.com trialx.com/clinical-trials/listings/298547/nt-101-topical-ophthalmic-solution-in-patients-with-wet-amd/

NT-101 Topical Ophthalmic Solution in Patients With Wet ... Clinical trial for Wet AMD | Wet Age Related Macular Degeneration , NT-101 Topical Ophthalmic Solution in Patients With Wet AMD.

5. trial.medpath.com trial.medpath.com/news/9bef95691cd7ca3f/nexthera-initiates-phase-1-2a-trial-of-nt-101-eye-drops-for-wet-amd-potentially-eliminating-need-for-injections

NexThera Initiates Phase 1/2a Trial of NT-101 Eye Drops for ... NexThera has enrolled the first patient in a Phase 1/2a clinical trial of NT-101, a novel eye drop treatment for wet AMD that could replace ...

6. withpower.com withpower.com/trial/phase-2-macular-degeneration-2025-a688b

NT-101 Eye Drops for Age-Related Macular Degeneration NT-101 Eye Drops are unique because they are a topical ophthalmic solution, which means they are applied directly to the eye, unlike most current treatments for ...

7. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06704009/nt-101-topical-ophthalmic-solution-in-patients-with-wet-amd

NT-101 Topical Ophthalmic Solution in Patients With Wet ... Inclusion Criteria: Subject who is male or female ≥ 50 years of age at Screening. Choroidal neovascularization (CNV) lesions secondary to AMD ...