66 Participants NeededMy employer runs this trial

NT-101 Eye Drops for Age-Related Macular Degeneration

Recruiting at 2 trial locations
YK
Overseen ByYoungwoon Kong, Bachelor's degree
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests eye drops known as NT-101 to determine their effectiveness for wet age-related macular degeneration (AMD), a condition affecting vision in older adults. The study will compare the effects of NT-101 drops to a placebo (a substance with no active drug) over 12 weeks. Individuals with wet AMD and fluid in their eyes affecting central vision might be suitable candidates, particularly if they have experienced frequent vision issues and are open to trying a new treatment. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

Is there any evidence suggesting that NT-101 ophthalmic solution is likely to be safe for humans?

Without clear data specific to NT-101 eye solution's safety, it is important to note that this trial is in the second phase of testing. This indicates that earlier studies have already demonstrated some level of safety. Generally, treatments must pass initial safety checks before reaching this phase. Although specific safety data on NT-101 is unavailable, its progression to this phase suggests it is likely well-tolerated by participants. More detailed information on safety and side effects will typically be collected during this phase.12345

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for age-related macular degeneration, which often include injections like anti-VEGF therapies directly into the eye, NT-101 eye drops offer a non-invasive alternative. Researchers are excited about NT-101 because it introduces a new delivery method—eye drops—that could be easier and more comfortable for patients to use regularly. This method potentially improves patient compliance and accessibility, offering a significant advantage over current treatment options that require frequent visits to a healthcare provider.

What evidence suggests that NT-101 eye drops might be an effective treatment for wet AMD?

Research has shown that NT-101 eye drops might help treat wet age-related macular degeneration (AMD). In earlier studies, patients who used NT-101 experienced better vision than those who did not receive the treatment. These eye drops reduce the growth of abnormal blood vessels that cause vision problems in wet AMD. Initial results indicate that the treatment is generally safe and can improve vision. While more research is needed to confirm these findings, current evidence suggests that NT-101 could be an effective treatment for wet AMD. Participants in this trial will receive either a high dose of NT-101 or a placebo to further evaluate its effectiveness and safety.

Are You a Good Fit for This Trial?

This trial is for adults diagnosed with wet age-related macular degeneration (AMD) who have issues with blood flow in the retina. Participants must meet specific health criteria set by the study and cannot join if they have certain other eye conditions or health problems.

Inclusion Criteria

I have fluid in the center of my retina seen on eye scans for wet AMD.
I can use eye drops as directed and will attend all study visits.
Understands and voluntarily signs an informed consent form
See 5 more

Exclusion Criteria

Estimated glomerular filtration rate < 30 mL/min/1.73m2 at Screening
Platelets < 100 × 10^3 µL at Screening
Positive results for HIV or Hepatitis B or C viruses at Screening
See 27 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Treatment

Participants receive NT-101 or placebo administered into the study eye twice daily for 12 weeks

12 weeks
Visits at Weeks 4, 8, and 12

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • NT-101 ophthalmic solution

Trial Overview

The study is testing NT-101 eye drops, given twice daily for 12 weeks, to see if they help people with wet AMD. Some participants will get NT-101 while others receive placebo drops; neither patients nor doctors know which one each person gets.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: NT-101 High Dose (0.2 mM)Experimental Treatment1 Intervention
Group II: Placebo (NT-101 without Drug Substance)Placebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

NexThera Co., Ltd.

Lead Sponsor

Trials
1
Recruited
30+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/20348131/

The effect of oral rehydration solution and ... - PubMed

We estimated that ORS may prevent 93% of diarrhoea deaths. Conclusions: ORS is effective against diarrhoea mortality in home, community and facility settings;

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/21645639/

Lactated Ringer's solution reduces systemic inflammation ...

Patients with acute pancreatitis who were resuscitated with lactated Ringer's solution had reduced systemic inflammation compared with those who received ...

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/12169076/

Hand-rubbing with an aqueous alcoholic solution vs ...

The hand-rubbing protocol was better tolerated by the surgical teams and improved compliance with hygiene guidelines.

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