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.

NCT03238963 | Completed Phase 2 Results FDA Drug

• 3 other identifiers: 1386-00122016-002971-911386.12
• Study Type: interventional
• Target: 79
• Locations: 8 countries
• Sites: 35

Brief Summary

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 Non-proliferative diabetic retinopathy (NPDR) (DRSS level 47) or severe Non-proliferative diabetic retinopathy (NPDR) (DRSS level 53), without Center-involved diabetic macular edema (CI-DME)

Conditions

Diabetic Retinopathy

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Any Ocular Adverse Events Over the On-treatment Period

  Percentage of participants with any ocular adverse events over the on-treatment period was reported.

  On-treatment period: from first dose of study drug until end of follow-up period, up to 24 weeks.

Secondary Outcomes (2)

• Percentage of Participants With at Least 2 Steps Improvement From Baseline in the Study Eye on the Diabetic Retinopathy Severity Scale (DRSS) at Week 12

  At baseline and at Week 12.

• Percentage of Participants With Adverse Events Other Than Ocular Adverse Events Over On-treatment Period

  On-treatment period: from first dose of study drug until end of follow-up period, up to 24 weeks.

Study Arms (2)

BI 1467335

EXPERIMENTAL

Drug: BI 1467335

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

BI 1467335 DRUG

Once daily

BI 1467335

Placebo DRUG

Once daily

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Of legal age (according to local legislation, usually ≥ 18 years) at screening
• Male or female patients. Women of childbearing potential (WOCBP) 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.
• Diagnosis of diabetes mellitus (type 1 or type 2):
• Documented diabetes by American Diabetes Association (ADA) and/or World Health Organization criteria
• Glycosylated hemoglobin (HbA1c) ≤ 12% at screening
• 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 Central reading center (CRC) by using the DR severity scale (DRSS)
• Best corrected visual acuity ETDRS letter score ≥ 70 letters in the study eye at screening
• Media clarity, pupillary dilation and individual cooperation sufficient for adequate retinal examination including fundus photographs and Optical Coherence Tomography (OCT)
• Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial

You may not qualify if:

• Cataract surgery performed within 6 months prior to screening or planned during the trial in the study eye; or any 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)
• Active center-involved DME (CI-DME) on clinical examination and Optical Coherence Tomography (OCT) central subfield thickness in the study eye above 300 μm as measured by Optovue OCT or above 320 μm as measured by Heidelberg OCT
• 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
• Prior pan-retinal photocoagulation (defined as ≥ 100 burns placed previously outside of the posterior pole) in the study eye
• Treatment of either DME or DR 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
• Patients treated with Monoamine Oxidase (MAO) inhibitors or drugs that may have potential side effects due to MAO inhibition
• Current or planned, during the trial, use of medications known to be toxic to the retina, lens or optic nerve, or cause vision loss
• Patients who must or wish to continue the intake of other restricted medications or any drug considered likely to interfere with the safe conduct of the trial
• Estimated Glomerular filtration rate (eGFR) \< 60 mL/min/1.73m2 calculated by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation at screening, or where the investigator expects filtration rate is likely to drop below 60 mL/min/1.73m2 during the trial
• Alanine transaminase (ALT) or aspartate transaminase (AST) greater than 2.0-fold the upper limit of normal, or total bilirubin \> 1.5x upper limit of normal.
• Uncontrolled arterial hypertension defined as a single measurement of systolic blood pressure \>180 mmHg, or two consecutive measurements of systolic blood pressure \> 160 mmHg and/or diastolic blood pressure \>100 mmHg on optimal medical regimen at screening. If blood pressure is brought to ≤ 160/100 mmHg by antihypertensive treatment until randomization, individual can become eligible.
• Wolff-Parkinson-White Syndrome, baseline QTc \> 450 ms (Fridericia's formula), family history of long QT, or on medication prolonging QT time at screening or planned initiation during the trial
• Diagnosis of a serious or unstable systemic or eye disease and other conditions that, in the clinical judgment of the investigator, are likely to interfere with the analyses of safety and efficacy in this study. Patients with an expected life expectancy of less than 2 years are also excluded.
• Active known or suspected chronic or relevant acute infections, such as HIV (Human Immunodeficiency Virus)\\viral hepatitis, or tuberculosis. QuantiFERON® TB test and HBs Ag test will be performed during screening. Patients with a positive test result may participate in the study if further work up (according to local practice/guidelines) establishes conclusively that the patient has no evidence of active infection.
• Any documented active or suspected malignancy or history of malignancy within 5 years prior to screening, except appropriately treated basal cell carcinoma of the skin or in situ carcinoma of uterine cervix.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (35)

Trinity Research

Dothan, Alabama, 36301, United States

Location

Retinal Research Institute, LLC

Phoenix, Arizona, 85053, United States

Location

Retina-Vitreous Associates Medical Group

Beverly Hills, California, 90211, United States

Location

Stanford University Medical Center

Palo Alto, California, 94303, United States

Location

Florida Retina Institute

Orlando, Florida, 32806, United States

Location

Northwestern Medical Group

Chicago, Illinois, 60611, United States

Location

Raj K. Maturi, MD PC

Indianapolis, Indiana, 46290, United States

Location

Cumberland Valley Retina Consultants, PC.

Hagerstown, Maryland, 21740, United States

Location

NJRetina

Teaneck, New Jersey, 07666, United States

Location

New York Eye and Ear Infirmary of Mount Sinai

New York, New York, 10003, United States

Location

Charlotte Eye Ear Nose and Throat Associates, PA

Charlotte, North Carolina, 28210, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Retina Research Institute of Texas

Abilene, Texas, 79606, United States

Location

Retina Research Center, PLLC

Austin, Texas, 78705, United States

Location

Retina Consultants of Houston, PA

Houston, Texas, 77030, United States

Location

LKH-Univ. Hospital Graz

Graz, 8036, Austria

Location

Interbalkan Medical Center of Thessaloniki

Thessaloniki, 57001, Greece

Location

Fondazione Centro San Raffaele del Monte Tabor

Milan, 20132, Italy

Location

IRCCS Fondazione Bietti

Roma, 00198, Italy

Location

Oslo Universitetssykehus HF, Ullevål sykehus

Oslo, N-0407, Norway

Location

CHUC - Centro Hospitalar e Universitário de Coimbra, EPE

Coimbra, 3000-075, Portugal

Location

Espaço Médico de Coimbra

Coimbra, 3030-163, Portugal

Location

CHULC, EPE - Hospital Sto. António Capuchos

Lisbon, 1169-050, Portugal

Location

Hospital Dos de Maig

Barcelona, 08025, Spain

Location

Hospital Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital Clínico San Carlos

Madrid, 28040, Spain

Location

Hospital Miguel Servet

Zaragoza, 50009, Spain

Location

Bradford Royal Infirmary

Bradford, BD9 6RJ, United Kingdom

Location

Bristol Eye Hospital

Bristol, BS1 2LX, United Kingdom

Location

Frimley Park Hospital

Frimley, GU16 7UJ, United Kingdom

Location

Moorfields Eye Hospital

London, EC1V 2PD, United Kingdom

Location

Royal Victoria Infirmary

Newcastle upon Tyne, NE1 4LP, United Kingdom

Location

Hospital of St Cross

Rugby, CV22 5PX, United Kingdom

Location

Sunderland Eye Infirmary

Sunderland, SR2 9HP, United Kingdom

Location

Related Links

• Related Info

MeSH Terms

Conditions

Diabetic Retinopathy

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2017
• First Posted: August 3, 2017
• Study Start: September 19, 2017
• Primary Completion: May 14, 2020
• Study Completion: May 14, 2020
• Last Updated: June 4, 2021
• Results First Posted: June 4, 2021

Record last verified: 2021-03

Locations

GR (1); IT (2); PT (3); AU (1); NO (1); ES (4); US (16); GB (7)