A Study to Evaluate THR-687 Treatment for Diabetic Macular Oedema.

Part of paid clinical trials in Huntington Beach, California.

Sponsor
Oxurion
Study ID
NCT05063734
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • THR-687 dose level 1 — DRUG
    3 intravitreal injections of THR-687 dose level 1, 1 month apart
  • THR-687 dose level 2 — DRUG
    3 intravitreal injections of THR-687 dose level 2, 1 month apart
  • THR-687 selected dose level — DRUG
    3 intravitreal injections of THR-687 selected dose level, 1 month apart, possibly followed by a 4th intravitreal injection with the same dose level of THR-687 at Month 3, or Month 4, or Month 5, if any of the PRN criteria are met.
  • Aflibercept — DRUG
    3 intravitreal injections of aflibercept, 1 month apart, possibly followed by a 4th intravitreal injection with aflibercept at Month 3, or Month 4, or Month 5, if any of the PRN criteria are met.

Study Details

This study is conducted to select the THR-687 dose level (Part A of the study) and to assess the efficacy and safety of the selected dose level compared to aflibercept (Part B of the study).

Key Dates

Start date
Aug 27, 2021
Status verified
Jul 2023
Primary completion
Jun 29, 2022
Completion
Jun 29, 2022

Study Design

Enrollment
16 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Part A, THR-687 1.2 mg
  • Experimental: Part A, THR-687 2.0mg
  • Experimental: Part B, treatment naïve subjects, THR-687 selected dose level
    Due to the discontinuation of the study after Part A, the dose level for Part B has not been selected
  • Active Comparator: Part B, treatment naïve subjects, aflibercept 2.0mg
  • Experimental: Part B, previously treated subjects, THR-687 selected dose level
    Due to the discontinuation of the study after Part A, the dose level for Part B has not been selected
  • Active Comparator: Part B, previously treated subjects, aflibercept 2.0mg

Primary Outcome Measure

Change From Baseline in BCVA ETDRS Letter Score, at Month 3, in Treatment-naïve Subjects in Part B of the Study [ Time Frame: At Month 3 ]

Locations (18)

FacilityCityStateZIPSite coordinators
Salehi Retina Institute Inc.Huntington BeachCalifornia92647-
California Eye Specialists Medical Group, Inc.PasadenaCalifornia91107-
Retinal Consultants Medical GroupSacramentoCalifornia95825-
Retina Consultants of Southern Colorado, P.C.Colorado SpringsColorado80909-
Retina Associates, LtdElmhurstIllinois60126-
University Retina and macula Associates, PCOak ForestIllinois60452-
Cumberland Valley Retina ConsultantsHagerstownMaryland21740-
Sierra Eye AssociatesRenoNevada89502-
Retina Vitreous Surgeons of Central New York, PCLiverpoolNew York13088-
Tulsa Retina ConsultantsTulsaOklahoma74114-
Eye Care SpecialistsKingstonPennsylvania18704-
Tennessee Retina, PCNashvilleTennessee37203-
Austin Research Center of RetinaAustinTexas78705-
Retina Consultants of TexasKatyTexas77494-
Valley Retina Institute, P.A.McAllenTexas78503-
Medical Center Ophthalmology AssociatesSan AntonioTexas78240-
Retina Center of TexasSouthlakeTexas76092-
Strategic Clinical Research GroupWillow ParkTexas76087-

Find similar trials in Huntington Beach, CA

By condition
Diabetic retinopathy
By specialty
OphthalmologyRetina
By research site
Salehi Retina Institute Inc.· Huntington Beach, CACalifornia Eye Specialists Medical Group, Inc.· Pasadena, CARetinal Consultants Medical Group· Sacramento, CARetina Consultants of Southern Colorado, P.C.· Colorado Springs, CORetina Associates, Ltd· Elmhurst, ILUniversity Retina and macula Associates, PC· Oak Forest, IL

Related Studies