NT-101 Eye Drops for Age-Related Macular Degeneration

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

30 Participants Needed

Trial Summary

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.

How is the drug NT-101 Eye Drops different from other treatments 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 age-related macular degeneration that involve injections or oral supplements. ^{1 2 3 4 5}

What is the purpose of this trial?

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

Eligibility Criteria

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

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

Treatment Details

Interventions

• NT-101 Topical Ophthalmic Solution

Participant Groups

Group I: NT-101 0.2 mM Experimental Treatment 1 Intervention

Group II: NT-101 0.05 mM 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+

Findings from Research

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Recent advances in the management and understanding of macular degeneration. [2019]

2. Canada pubmed.ncbi.nlm.nih.gov

The Efficacy, Safety, and Efficiency of the Off-Label Use of Bevacizumab in Patients Diagnosed With Age-Related Macular Degeneration: Protocol for a Systematic Review and Meta-Analysis. [2023]

3. China pubmed.ncbi.nlm.nih.gov

[Summarize drug dosage forms in treatment of age-related macular degeneration disease]. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Nutritional Supplements for Age-Related Macular Degeneration. [2020]

5. Czech Republic pubmed.ncbi.nlm.nih.gov

[Age-related macular degeneration--contemporary possibilities of treatment]. [2016]