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-DE
• Lead Sponsor: ovartis Pharma AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-10-01
• Last Update Posted: 21 June 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 90

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 72 letters inclusive (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 = 320µm in the central subfield, as assessed on spectral-domain ocular coherence tomography (SD-OCT) and confirmed by the central reading center at screeening
•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 at screening

Please refer to the protocol for a comprehensive list of inclusion criteria
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 treatment for DME in the study eye as defined
by the following:
- IVT anti-vascular endothelial growth factor (VEGF) treatment within 90
days before baseline in the study eye. History or concurrent treatment
with these medications/procedures in the non study eye is permitted.
- Patient with history of intraocular corticosteroids in the study eye
including dexamethasone intravitreal implants during the 6 month
period prior to baseline. Any prior use of fluocinolone acetonide intravitreal implant (Iluvien) is prohibited regardless of timing.
• Concomitant conditions or ocular disorders in the study eye which may, in the opinion of the investigator, confound the interpretation of study results, compromise visual acuity or require medical or surgical intervention during the study period:
- High risk proliferative diabetic retinopathy in the study eye, as per investigator assessment at both screening and baseline.
- Patients with the following conditions in the study eye at screening or baseline must be excluded: structural damage of the fovea, vitreous hemorrhage, retinal detachment, vitreomacular traction, macular hole, retinal vein/arterial occlusion, neovascularization of iris or choroidal neovascularization of any cause)
3. Laser photocoagulation (macular or panretinal) in the study eye during the 3-month period prior to baseline.
• 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 other than those listed in the
inclusion criteria.
• Area of retinal ischemia involving the macula (as measured by the
foveal avascular zone) = 1000 µm in linear diameter.
• Active intraocular inflammation (graded as trace or above) in either
eye or active intraocular infection in the study eye.
• Active infection involving the study eye's ocular adnexa including
infectious conjunctivitis, keratitis, scleritis, endophthalmitis, as well as
idiopathic or
autoimmune-associated uveitis in either eye, or intraocular infection in
either eye.
• Any intraocular surgery (except uncomplicated cataract surgery) in the study eye within the past 6 months preceding Day 1. Uncomplicated cataract surgery (e.g. routine surgery with no intra or post operative complications) within the past 3 months preceding Day 1. Yttrium-Aluminum-Garnet (YAG) laser capsulotomy within the past 30 days preceding baseline.
• Current diagnosis of clinically significant anemia, or hemoglobin <10
g/dL for women and <11 g/dL for men.
Please refer to the protocol for a comprehensive list of exclusion criteria

Study & Design

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