A study that tests BI 1467335 in patients with diabetic eye disease (diabetic retinopathy). It looks at the way BI 1467335 is taken up, the effects it has, and how well it is tolerated.
- Conditions
- diabetic retinopathyMedDRA version: 20.1Level: LLTClassification code 10054109Term: Non-proliferative diabetic retinopathySystem Organ Class: 100000004853Therapeutic area: Diseases [C] - Eye Diseases [C11]
- Registration Number
- EUCTR2016-002971-91-ES
- Lead Sponsor
- Boehringer Ingelheim España, S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 288
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
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
- Primary Outcome Measures
Name Time Method Secondary Objective: Not applicable;Primary end point(s): 1) proportion of patients with any ocular adverse events (according to Common Terminology Criteria for Adverse Events (CTCAE);Timepoint(s) of evaluation of this end point: 1) 24 weeks;Main Objective: The main objective is to evaluate ocular and systemic safety and tolerability of BI 1467335 as well as whether BI 1467335 monotherapy has a potential to improve retinal lesions in patients with moderately severe NPDR (DRSS level 47) or severe NPDR (DRSS level 53), without CI-DME.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1) Proportion of patients with at least 2 steps improvement in the study eye on the DRSS at week 12 compared to baseline.<br>2) The proportion of patients with adverse events other than ocular adverse events over the on treatment period (over 24 weeks) (according to CTCAE).;Timepoint(s) of evaluation of this end point: 1) 12 weeks<br>2) 24 weeks