A Study Intravitreal THN391 in Diabetic Macular Oedema Secondary to Non-Proliferative Diabetic Retinopathy.

Sponsor
Therini Bio Pty Ltd
Study ID
NCT06701721
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • THN391 — DRUG
    THN391, IVT injection, 3\*Q4W (every 4 weeks)

Study Details

THN391-OPT-101 is a study assessing safety and preliminary efficacy of THN391 in patients with diabetic macular edema (DME) given as monotherapy.

Key Dates

First listed
Nov 22, 2024
Start date
Dec 20, 2024
Status verified
Jun 2026
Primary completion
Mar 31, 2027
Completion
May 31, 2027

Study Design

Enrollment
21 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1
    THN 391 (low dosage), IVT injection
  • Experimental: Cohort 2
    THN 391 (medium dosage), IVT injection
  • Experimental: Cohort 3
    THN 391 (high dosage), IVT injection

Primary Outcome Measure

Adverse Events [ Time Frame: Up to 16 weeks following first dose administration ]

Central Contacts

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Diabetic retinopathy trialsOphthalmology trialsRetina trials

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