A Study to Evaluate THR-149 Treatment for Diabetic Macular Oedema

Conditions

• Diabetes Mellitus
• Diabetic Macular Edema
• Diabetic Retinopathy

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• THR-149 dose level 1 — DRUG
  3 intravitreal injections of THR-149 dose level 1, 1 month apart
• THR-149 dose level 2 — DRUG
  3 intravitreal injections of THR-149 dose level 2, 1 month apart
• THR-149 dose level 3 — DRUG
  3 intravitreal injections of THR-149 dose level 3, 1 month apart
• THR-149 0.13mg — DRUG
  3 intravitreal injections of THR-149 0.13mg (selected dose level), 1 month apart, followed after 1 month by a sham (pretend) injection
• THR-149 0.13mg + aflibercept 2mg — DRUG
  3 intravitreal injections of THR-149 0.13mg (selected dose level), 1 month apart, followed after 1 month by an intravitreal injection of aflibercept 2mg
• aflibercept 2mg + THR-149 0.13mg — DRUG
  3 intravitreal injections of aflibercept 2mg, 1 month apart, followed after 1 month by an intravitreal injection of THR-149 0.13mg (selected dose level)
• Aflibercept 2mg — DRUG
  3 intravitreal injections of aflibercept 2mg, 1 month apart, followed after 1 month by a sham (pretend) injection

Study Details

Part A of the study is conducted to select the THR-149 dose level. Part B of the study is conducted to assess the efficacy and safety of the selected dose level compared to aflibercept, up to Month 3. As from Month 3, in about half of the subjects, the effect of a single flip-over injection (aflibercept or THR-149) will be evaluated when administered 1 month after the 3 monthly injections of THR-149 or aflibercept. In the other subjects, the durability of 3 monthly injections of THR 149 or aflibercept will be evaluated.

Key Dates

Start date

Jul 31, 2020

Status verified

Nov 2023

Primary completion

Sep 28, 2023

Completion

Nov 22, 2023

Study Design

Enrollment

135 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: THR-149 dose level 1
• Experimental: THR-149 dose level 2
• Experimental: THR-149 dose level 3
• Experimental: THR-149 + sham
• Experimental: THR-149 + aflibercept flip-over
• Active Comparator: Aflibercept + THR-149 flip-over
• Active Comparator: Aflibercept + sham

Primary Outcome Measure

Mean change in best-corrected visual acuity (BCVA) ETDRS letter score from Baseline, in subjects in Part B of the study [ Time Frame: At Month 3 ]

Locations (41)

Find similar trials in Phoenix, AZ

Related Studies

• Genetic Studies of Insulin and Diabetes
  Recruiting · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · Bethesda, Maryland
• National Eye Institute Biorepository for Retinal Diseases
  Recruiting · National Eye Institute (NEI) · Bethesda, Maryland
• Inflammation, Diabetes, Ethnicity and Obesity Cohort
  Recruiting · University of California, San Francisco · San Francisco, California
• Clinical Applications of Advanced Ophthalmic Imaging
  Recruiting · University of Miami · Miami, Florida