A Proof of concept study of intravitreal LKA651 in patients with macular edema

Phase 1

• Conditions: diabetic macular edema; MedDRA version: 20.1Level: LLTClassification code 10057934Term: Diabetic macular edemaSystem Organ Class: 100000004853; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2018-000031-28-ES
• Lead Sponsor: ovartis Farmacéutica, S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-10-09
• Study Completion: 2022-08-31
• Last Update Posted: 23 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 91

Inclusion Criteria

•Male and female patients age 18 to 90 years of age inclusive
•Diagnosis of type I or type II diabetes mellitus.
•The Early Treatment Diabetic Retinopathy Study (ETDRS) letter score in the study eye must be between 24 and 70 letters (approximate Snellen equivalent of 20/40-20/320). The non-study eye (fellow eye) should be =34 letters or better (approximate Snellen equivalent of 20/200) at screening
•Presence of DME in the study eye, with decrease in vision due to foveal thickening of central macular thickness = 275 µm in the central subfield, as assessed on spectral-domain ocular coherence tomography (SD-OCT) and confirmed by the central reading center
•Sufficiently clear ocular media and adequate pupil dilation in the study eye to permit fundus photographs of adequate clarity to measure diameters of retinal arteries and veins
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 35
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 55

Exclusion Criteria

•Patient with history of IVT anti-vascular endothelial growth factor (VEGF) treatment, macular laser photocoagulation, or intravitreal or topical steroid treatment in the study eye. History of topical steroid >6 months from study start for treatment of non-DME condition is allowed. History of focal laser treatment outside 1000 µm of the fovea in the study eye is permitted. History or concurrent treatment with these medications/procedures in the non-study eye is permitted.
•Proliferative diabetic retinopathy in the study eye, with the exception of tufts of neovascularization less than one disc area with no vitreous hemorrhage. Proliferative diabetic retinopathy in the study eye for which only focal, peripheral retinal areas were treated with photocoagulation with fewer than 30 laser burns performed at least 6 months preceding Day 1 is permitted.
•Patients, with type 1 or type 2 diabetes who have a hemoglobin A1C = 12% at screening.
•Any progressive disease of the retina in the study eye (e.g. uveitis, rod-cone dystrophy) or optic nerve (e.g. glaucoma) other than those listed in the inclusion criteria.
•Area of retinal ischemia (as measured by the foveal avascular zone) = 1000 µm. Any other retinal ischemia not involving the foveal center but located = 1000 µm from the center of the macula of the study eye as assessed by fluorescein angiography (FA) at screening.
•Active intraocular inflammation (graded as trace or above) in either eye or active intraocular infection in the study eye.
•Current diagnosis of or laboratory evidence for anemia, defined as a hemoglobin <11 g/dL for women and <12 g/dL for men.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified