Health TrialsbyHealthPanel

A Phase 2 Study of NT-101 Topical in Patients With Wet AMD

ConditionWet Age Related Macular Degeneration
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age50+
SponsorNexThera Co., Ltd.

About this trial

This phase 2 trial is a randomized, double-blind, placebo-controlled, multicenter study in patients with wet AMD to assess the efficacy and safety of NT-101 topical ophthalmic solution (0.20 mM) administered into the study eye twice daily (BID) for 12 weeks.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subject who is male or female ≥ 50 years of age 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.

BCVA between 35 and 78 letters, inclusive, in the study eye at Screening using ETDRS testing, with BCVA decrement primarily attributable to wet AMD.

Disqualifiers

Subject who has the following illness or abnormal laboratory test values at

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • NT-101 ophthalmic solution

    Drug

    NT-101 is a topical ophthalmic solution containing pigment epithelium-derived factor (PEDF) 34 and type I atelocollagen

  • Placebo

    Drug

    NT-101 without Drug Substance

Treatment groups

66 Participants
are divided into 2 treatment groups
Group A: NT-101 High Dose (0.2 mM)Experimental treatment 1 intervention
Group B: Placebo (NT-101 without Drug Substance)Placebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in Early Treatment Diabetic Retinopathy Study (ETDRS) BCVA in the study eye at Week 12 compared to baseline

Time frame
Week 12 compared to baseline

Secondary outcomes

1

Change in ETDRS BCVA letter score

Time frame
at Weeks 4, 8 and 12 compared to baseline
2

Change in CST in the study eye assessed by spectral-domain optical coherence tomography (SD-OCT)

Time frame
at Weeks 4, 8 and 12 compared to baseline
3

Change in Macular Volume (MV)

Time frame
at Weeks 4, 8 and 12 compared to baseline
4

Change in IOP (intraocular pressure)

Time frame
at Weeks 4, 8 and 12 compared to baseline

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

NexThera Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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