A study that tests BI 1467335 in patients with diabetic eyedisease (diabetic retinopathy). It looks at the way BI 1467335 istaken up, the effects it has, and how well it is tolerated.

Phase 1

• Conditions: diabetic retinopathy; MedDRA version: 20.1Level: LLTClassification code 10054109Term: Non-proliferative diabetic retinopathySystem Organ Class: 100000004853; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2016-002971-91-GR
• Lead Sponsor: Boehringer Ingelheim Ellas SA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-09-28
• Last Update Posted: 8 June 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Of full age (according to local legislation, usually = 18 years) and = 80 years at screening
2. Male or female patients. Women of childbearing potential (WOCBP)1 must be ready and
able to use two methods of contraception with at least one of them being a highly
effective method of birth control per ICH M3 (R2) that result in a low failure rate of less
than 1% per year when used consistently and correctly. A list of contraception methods
meeting these criteria is provided in the patient information.
3. Diagnosis of diabetes mellitus (type 1 or type 2):
- Documented diabetes by American Diabetes Association (ADA) and/or World Health
Organization criteria
- Antidiabetic medication stable for =3 months prior to screening and expected to be
stable throughout the trial (no change in medication or the dose, except for insulin the
prescribed total daily dose change not more than 10%)
4. Glycosylated hemoglobin (HbA1c) = 10% at screening
5. Non-proliferative diabetic retinopathy (NPDR) without center-involved diabetic macular
edema (CI-DME) in the study eye at screening with NPDR level 47 or level 53, as
determined by the CRC by using the DR severity scale (DRSS)
6. Best corrected visual acuity ETDRS letter score = 70 letters in the study eye at screening
7. Media clarity, pupillary dilation and individual cooperation sufficient for adequate retinal
examination including fundus photographs and OCT
8. Signed and dated written informed consent in accordance with ICH-GCP and local
legislation prior to admission to the trial
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 80
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

1. Additional eye disease in the study eye that, in the opinion of the investigator, could
compromise or alter visual acuity during the course of the study (e.g. vein occlusion,
uncontrolled intraocular pressure (IOP) >24 mmHg on optimal medical treatment,
glaucoma with visual field loss, uveitis or other ocular inflammatory disease,
vitreomacular traction, monocular vision, history of ischemic optic neuropathy, or genetic
disorders such as retinitis pigmentosa)
2. Active center-involved DME (CI-DME) on clinical examination and OCT central
subfield thickness above 300 µm in the study eye, as measured by Optovue OCT
3. Anterior segment and vitreous abnormalities in the study eye that would compromise the
adequate assessment of the best corrected visual acuity or an adequate examination of the
posterior pole
4. Evidence of neovascularization on clinical examination including active
neovascularization of the iris (small iris tufts are not an exclusion) or angle
neovascularization in the study eye, ruled out by gonioscopy (documented in the last 4
weeks before screening or performed at screening)
5. Prior pan-retinal photocoagulation (defined as = 100 burns placed previously outside of
the posterior pole) in the study eye
6. History of DME or DR treatment with macular laser within 3 months prior to screening,
or intraocular injections of medication within 6 months prior to screening, and no more
than 4 prior intraocular injections in the study eye at any time in the past
7. Patients treated with Monoamine Oxidase B (MAO-B) inhibitors (see Section 4.2.2.1) at
the time or up to 3 months prior to randomization or planned initiation during the trial
8. Current or planned, during the trial, use of medications known to be toxic to the retina,
lens or optic nerve, or cause vision loss
Further criteria apply.

Study & Design

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