Diabetic RetinopathyPhase 2ROBINNCT03238963
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.
A Phase 2 study testing BI 1467335 in people with Diabetic Retinopathy, run by Boehringer Ingelheim at 35 sites in 8 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetic Retinopathy
- What is being tested?
- BI 1467335
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 79 participants
- Where
- 35 sitesin 8 countries
- Study dates
- 19 Sep 2017to 14 May 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
- 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
- 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
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- 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.
- 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.
Trial locations and contacts
35 sites in 8 countries.
35 sites in 8 countries
United States16 sites
Retina Research Institute of Texas
Abilene, Texas, 79606
Retina Research Center, PLLC
Austin, Texas, 78705
Retina-Vitreous Associates Medical Group
Beverly Hills, California, 90211
Charlotte Eye Ear Nose and Throat Associates, PA
Charlotte, North Carolina, 28210
Northwestern Medical Group
Chicago, Illinois, 60611
Cleveland Clinic
Cleveland, Ohio, 44195
Trinity Research
Dothan, Alabama, 36301
Cumberland Valley Retina Consultants, PC.
Hagerstown, Maryland, 21740
Retina Consultants of Houston, PA
Houston, Texas, 77030
Raj K. Maturi, MD PC
Indianapolis, Indiana, 46290
New York Eye and Ear Infirmary of Mount Sinai
New York, New York, 10003
Florida Retina Institute
Orlando, Florida, 32806
Stanford University Medical Center
Palo Alto, California, 94303
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Retinal Research Institute, LLC
Phoenix, Arizona, 85053
NJRetina
Teaneck, New Jersey, 07666
United Kingdom7 sites
Bradford Royal Infirmary
Bradford, BD9 6RJ
Bristol Eye Hospital
Bristol, BS1 2LX
Frimley Park Hospital
Frimley, GU16 7UJ
Moorfields Eye Hospital
London, EC1V 2PD
Royal Victoria Infirmary
Newcastle upon Tyne, NE1 4LP
Hospital of St Cross
Rugby, CV22 5PX
Sunderland Eye Infirmary
Sunderland, SR2 9HP
Spain4 sites
Hospital Dos de Maig
Barcelona, 08025
Hospital Vall d'Hebron
Barcelona, 08035
Hospital Clínico San Carlos
Madrid, 28040
Hospital Miguel Servet
Zaragoza, 50009
Portugal3 sites
CHUC - Centro Hospitalar e Universitário de Coimbra, EPE
Coimbra, 3000-075
Espaço Médico de Coimbra
Coimbra, 3030-163
CHULC, EPE - Hospital Sto. António Capuchos
Lisbon, 1169-050
Italy2 sites
Fondazione Centro San Raffaele del Monte Tabor
Milan, 20132
IRCCS Fondazione Bietti
Roma, 00198
About this study
Official title: 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)
- Conditions
- Diabetic Retinopathy
- Being tested
- BI 1467335, Placebo
- Medical subject headings
- Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 1467335Drug
Once daily
PlaceboDrug
Once daily
| Study group | Role | What they receive |
|---|---|---|
| BI 1467335 | Experimental | Not described Receives: Drug: BI 1467335 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
7-field or modified 4-field digital fundus photographs was obtained from both eyes by a qualified person according to the imaging manual to collect all data for the assessment of the Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS). The images was sent to the independent central reading center who performs the grading on the basis of the DRSS. The DRSS ranges from level 10 (Diabetic retinopathy absent) to level 85 (advanced proliferative Diabetic retinopathy).
Measured: At baseline and at Week 12.
Percentage of Participants With Adverse Events Other Than Ocular Adverse Events Over On-treatment Period
Percentage of participants with adverse events other than ocular adverse events over on-treatment period was reported.
Measured: On-treatment period: from first dose of study drug until end of follow-up period, up to 24 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2017
- Study start19 Sep 2017
- Primary completion14 May 2020
- Study completion14 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetic RetinopathyStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03238963
- Sponsor's protocol ID
- 1386-0012
- Other IDs
- 2016-002971-91, 1386.12, 2016
- Acronym
- ROBIN
- Status last verified
- Mar 2021
- First submitted
- 1 Aug 2017
- Last updated
- 4 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT03238963
- Acronym / sponsor ID
- ROBIN / 1386-0012
- Conditions
- Diabetic Retinopathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 19 Sep 2017 (actual)
- Primary completion
- 14 May 2020 (actual)
- Study completion
- 14 May 2020 (actual)
- First posted
- 3 Aug 2017 (actual)
- Results
- Posted 4 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BI 1467335 | Experimental | Drug: BI 1467335 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (23 listed)
- 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
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BI 1467335Once daily | Drug | BI 1467335 |
| PlaceboOnce daily | Drug | Placebo |
Primary outcome
Percentage of Participants With Any Ocular Adverse Events Over the On-treatment Period
Time frame: On-treatment period: from first dose of study drug until end of follow-up period, up to 24 weeks.
Percentage of participants with any ocular adverse events over the on-treatment period was reported.
2 secondary outcomes
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
Time frame: At baseline and at Week 12.
Percentage of Participants With Adverse Events Other Than Ocular Adverse Events Over On-treatment Period
Time frame: On-treatment period: from first dose of study drug until end of follow-up period, up to 24 weeks.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
35 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BI 1467335 in people with Diabetic Retinopathy, run by Boehringer Ingelheim at 35 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in United States, United Kingdom, Spain, Portugal, Italy and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Any Ocular Adverse Events Over the On-treatment Period (time frame: On-treatment period: from first dose of study drug until end of follow-up period, up to 24 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2021; AzTrials last refreshed its copy on 1 Nov 2026.