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.



Status:Recruiting
Conditions:Ocular, Diabetes
Therapuetic Areas:Endocrinology, Ophthalmology
Healthy:No
Age Range:18 - 80
Updated:4/4/2019
Start Date:September 19, 2017
End Date:January 21, 2020
Contact:Boehringer Ingelheim
Email:clintriage.rdg@boehringer-ingelheim.com
Phone:1-800-243-0127

Use our guide to learn which trials are right for you!

A Randomized, Double-masked, Placebo-controlled Exploratory Study to Evaluate Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Orally Administered BI 1467335 for 12 Weeks With a 12 Week Follow up Period in Patients With Non-proliferative Diabetic Retinopathy Without Center-involved Diabetic Macular Edema (ROBIN Study)

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)


Inclusion Criteria:

- 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

Exclusion Criteria:

- Cataract surgery performed within 6 months prior to screening or planned during the
trial;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

- 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)

- Prior pan-retinal photocoagulation (defined as ≥ 100 burns placed previously outside
of the posterior pole) in the study eye

- 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

- 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, 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.

- Chronic alcohol or drug abuse or any condition that, in the investigator's opinion,
makes them an unreliable study participant or unlikely to complete the trial

- Known hypersensitivity to any component of the trial drug and/or allergy to
fluorescein dye

- Major surgery (major according to the investigator's assessment) performed within 12
weeks prior to randomization or planned during the trial, e.g. hip replacement

- Currently enrolled in another investigational drug trial, or less than 30 days or 5
times half-life of the investigational drug, whichever is longer, since ending another
investigational drug trial from the screening visit in this trial or receiving other
investigational treatment(s); patients participating in a purely observational trial
will not be excluded.

- Previous randomization in this trial

- Women who are pregnant, nursing, or who plan to become pregnant while in the trial

- Any other clinical condition that, in the opinion of the investigator, would
jeopardize patient safety while participating in this clinical trial.
We found this trial at
15
sites
Palo Alto, California 94304
Phone: +001 (650) 724-4280
?
mi
from
Palo Alto, CA
Click here to add this to my saved trials
9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Phone: +001 (216) 636-0183
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
Abilene, Texas 79606
Phone: +001 (325) 690-4414
?
mi
from
Abilene, TX
Click here to add this to my saved trials
Austin, Texas 78705
Phone: +001 (512) 454-0138
?
mi
from
Austin, TX
Click here to add this to my saved trials
Beverly Hills, California 90211
Phone: +001 (310) 289-2478 x 3
?
mi
from
Beverly Hills, CA
Click here to add this to my saved trials
One Joslin Place
Boston, Massachusetts 02215
617-309-2400
Phone: +001 (617) 309-2554
Joslin Diabetes Center Joslin Diabetes Center, located in Boston, Massachusetts, is the world's largest diabetes...
?
mi
from
Boston, MA
Click here to add this to my saved trials
Charlotte, North Carolina 28210
Phone: +001 (704) 295-3390
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
Chicago, Illinois 60611
Phone: +001 (312) 908-8152
?
mi
from
Chicago, IL
Click here to add this to my saved trials
Hagerstown, Maryland 21740
Phone: +001 (301) 665-1712 ext 205
?
mi
from
Hagerstown, MD
Click here to add this to my saved trials
Houston, Texas 77030
Phone: +001 (713) 524-3434
?
mi
from
Houston, TX
Click here to add this to my saved trials
Indianapolis, Indiana 46290
Phone: +001 (317) 817-1414
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
New York, New York 10003
Phone: +001 (212) 979-4024
?
mi
from
New York, NY
Click here to add this to my saved trials
3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Phone: +001 (215) 662-9702
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Phoenix, Arizona 85014
Phone: +001 (602) 222-2221
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
23 Spitalgasse
Vienna, 1090
Phone: +4314040079400
?
mi
from
Vienna,
Click here to add this to my saved trials