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

Active, not recruiting

• 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-IT
• Lead Sponsor: BOEHRINGER-INGELHEIM ITALIA S.P.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-02-06
• Last Update Posted: 30 November 2020

Recruitment & Eligibility

• Status: Not 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 ICHGCP
and local
legislation prior to admission to the trial
Are the trial subjects under 18? no
Number of subjects for this age range: 1
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

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: The main objective is to evaluate ocular and systemic safety and<br>tolerability of BI 1467335 as<br>well as whether BI 1467335 monotherapy has a potential to improve<br>retinal lesions in<br>patients with moderately severe NPDR (DRSS level 47) or severe NPDR<br>(DRSS level 53),<br>without CI-DME.;Secondary Objective: N.A.;Primary end point(s): 1) proportion of patients with any ocular adverse events (according to<br>Common Terminology Criteria for Adverse Events (CTCAE);Timepoint(s) of evaluation of this end point: 1) 24 weeks

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1) Proportion of patients with at least 2 steps improvement in the study<br>eye on the DRSS at week 12 compared to baseline.<br>2) The proportion of patients with adverse events other than ocular<br>adverse events over the on treatment period (over 24 weeks) (according<br>to CTCAE).;Timepoint(s) of evaluation of this end point: 1) 12 weeks<br>2) 24 weeks