Clinical trial NCT03511898: A Study to Evaluate the Safety of THR-149 in Subjects With Diabetic Macular Edema (DME)
Official title: A Phase 1, Open-label, Multicenter, Dose Escalation Study to Evaluate the Safety of a Single Intravitreal Injection of THR-149 for the Treatment of Diabetic Macular Edema (DME)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus
Diabetic Retinopathy
Diabetic Macular Edema
Lead sponsor: Oxurion
Sponsor class: INDUSTRY
First posted: 2018-04-30
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This study is conducted to evaluate the safety of a single intravitreal injection of THR-149.


Eligibility criteria: Inclusion Criteria:

* Male or female aged 18 years or older
* Type 1 or type 2 Diabetes Mellitus
* Central-involved DME with central subfield thickness of ≥ 320µm on Spectralis® spectral domain optical coherence tomography (SD-OCT) or ≥ 305µm on non-Spectralis SD-OCT, in the study eye
* Best-corrected visual acuity (BCVA) ≤ 62 and ≥ 23 ETDRS letter score in the study eye
* Written informed consent obtained from the subject prior to screening procedures

Exclusion Criteria:

* Macular edema due to causes other than DME
* Concurrent disease in the study eye, other than central-involved DME, that could compromise BCVA, require medical or surgical intervention during the study period or could confound interpretation of the results
* Any condition that could confound the ability to detect a change in central subfield thickness in the study eye
* Previous confounding treatments / procedures, or their planned / expected use during the study period
* Presence of neovascularization at the disc (NVD) in the study eye
* Uncontrolled glaucoma in the study eye
* Any active ocular / intra-ocular infection or inflammation in either eye
* Poorly controlled Diabetes Mellitus
* Uncontrolled hypertension

Primary outcomes:
measure: Incidence of dose-limiting toxicities up to the Day 14 visit
timeFrame: up to Day 14
Secondary outcomes:
measure: Incidence of systemic and ocular adverse events including serious adverse events up to the end of the study
timeFrame: From Day 0 up to Day 84
measure: Occurrence of laboratory abnormalities up to the end of the study
timeFrame: At Screening, Day 1, Day 7, Day 28 and Day 84
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Retina Consultants of Arizona
state: Arizona
city: Boston
country: United States
facility: Ophthalmic Consultants of Boston
state: Massachusetts
city: Reno
country: United States
facility: Sierra Eye Associates
state: Nevada
city: Huntingdon Valley
country: United States
facility: Mid Atlantic Retina
state: Pennsylvania
city: Abilene
country: United States
facility: Retina Research Institute of Texas
state: Texas
city: Austin
country: United States
facility: Retinal Research Center, PLLC
state: Texas
city: Houston
country: United States
facility: Retina Consultants of Houston
state: Texas
Study officials:
affiliation: ThromboGenics
name: Clinical Department
role: STUDY_DIRECTOR
References: