A Study to Investigate the Efficacy and Safety of RG7774 in Patients With Diabetes Mellitus Type 1 or Type 2 With Treatment-Naive Diabetic Retinopathy
NCT ID: NCT04265261
Last Updated: 2024-09-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
139 participants
INTERVENTIONAL
2020-06-05
2023-07-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Group A
Participants will receive an oral dose of placebo matched to RG7774 once daily (QD)
Placebo
Participants will receive oral placebo matched to RG7774
Group B
Participants will receive a low oral dose of RG7774 QD
RG7774
Participants will receive oral RG7774
Group C
Participants will receive a high oral dose of RG7774 QD
RG7774
Participants will receive oral RG7774
Interventions
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Placebo
Participants will receive oral placebo matched to RG7774
RG7774
Participants will receive oral RG7774
Eligibility Criteria
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Inclusion Criteria
* Male and female patients of at least 18 years of age
* Treatment naïve with moderately severe to severe NPDR defined as ETDRS DRSS 47 or 53
* Patients are eligible with and without DME in either eye
* BCVA score at screening of at least 70 letters in study eyes without DME and at least 75 letters in case DME is present
* Clear ocular media and adequate pupillary dilation to allow acquisition of good quality retinal images.
* Diagnosis of diabetes mellitus (DM) type 1 or type 2
* Hemoglobin A1c (HbA1c) \</= 12%.
* A female is eligible to participate if she is not pregnant, not breastfeeding
Exclusion Criteria
* Prior treatment for DR or other retinal diseases with any approved or investigational therapy, including but not limited to intravitreal steroids, intravitreal anti-VEGF, light therapy, periocular pharmacological intervention, and laser (e.g. focal, grid, micropulse, or pan-retinal)
* Uncontrolled glaucoma
* Any concurrent intraocular condition (e.g. retinal detachment, dense cataract, epiretinal membrane with traction, or vitreomacular traction, etc.) that in the opinion of the Investigator could reduce the potential for improvement, require medical surgical intervention or may confound the visual and functional assessment and interpretation of study results
Concurrent ocular conditions in either eye:
* Any active ocular infection
* Any active intraocular inflammation
General Criteria:
* Previous systemic use of anti-VEGF drugs within 6 months prior to screening
* Complications of diabetes such as end-stage renal disease or liver disease
* Currently untreated diabetes mellitus or previously untreated patients who initiated oral or injectable anti-diabetic medication within 3 months prior to screening
* Uncontrolled blood pressure (\[BP\] defined as systolic \> 180mmHg and/or diastolic \>100 mmHg while patient at rest)
* History of concurrent cardio-vascular disease not considered well controlled by the Investigator
* Any major illness or major surgical procedure within one month before screening
* History of or currently active other diseases, metabolic dysfunction, physical examination finding, malignancies not considered cured, or clinical laboratory findings giving reasonable suspicion of a condition that contraindicated the use of the investigational medicinal drug or that might affect interpretation of the results of the study or renders the patient at high risk for treatment complications in the opinion of the investigator
* Known hypersensitivity to any of the excipients of the drug used, fluorescein dye or dilating eye drops
* Use of systemic medications known to be toxic to the lens, retina or optic nerve (e.g., deferoxamine, chloroquine/hydroxychloroquine, tamoxifen, phenothiazines and ethambutol) used during the 6-month period prior to screening or likely need to be used
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Arizona Retina and Vitreous Consultants
Phoenix, Arizona, United States
Retina Associates Tucson
Tucson, Arizona, United States
Win Retina
Arcadia, California, United States
Global Research Management
Glendale, California, United States
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Torrance, California, United States
Retina Consultants of Southern Colorado PC
Colorado Springs, Colorado, United States
Retina Group of New England
Waterford, Connecticut, United States
Rand Eye
Deerfield Beach, Florida, United States
Florida Retina Consultants
Lakeland, Florida, United States
Florida Eye Associates
Melbourne, Florida, United States
Medeye Associates
Miami, Florida, United States
Retina Specialty Institute
Pensacola, Florida, United States
Retina Vitreous Assoc of FL
St. Petersburg, Florida, United States
Southeast Retina Center
Augusta, Georgia, United States
Marietta Eye Clinic
Marietta, Georgia, United States
Retina Associated Ltd
Elmhurst, Illinois, United States
University Retina and Macula Associates, PC
Oak Forest, Illinois, United States
Cumberland Valley Retina PC
Hagerstown, Maryland, United States
University of Michigan, Kellogg Eye Center
Ann Arbor, Michigan, United States
Deep Blue Retina PLLC
Southaven, Mississippi, United States
Sierra Eye Associates
Reno, Nevada, United States
Envision Ocular, LLC
Bloomfield, New Jersey, United States
Eye Associates of New Mexico
Albuquerque, New Mexico, United States
Velocity Clinical Research
East Syracuse, New York, United States
Ophthalmic Consultants of Long Island
Oceanside, New York, United States
Charlotte Eye Ear Nose and Throat Associates
Charlotte, North Carolina, United States
EyeHealth Northwest
Portland, Oregon, United States
Erie Retinal Surgery
Erie, Pennsylvania, United States
Charleston Neuroscience Institute
Ladson, South Carolina, United States
Southeastern Retina Associates Chattanooga
Chattanooga, Tennessee, United States
Charles Retina Institute
Germantown, Tennessee, United States
Retina Res Institute of Texas
Abilene, Texas, United States
Austin Clinical Research LLC
Austin, Texas, United States
San Antonio Eye Center
San Antonio, Texas, United States
Retina Consultants of Texas
The Woodlands, Texas, United States
Retinal Consultants of Houston
The Woodlands, Texas, United States
Strategic Clinical Research Group, LLC
Willow Park, Texas, United States
Sydney Eye Hospital
Sydney, New South Wales, Australia
Sydney Retina Clinic and Day Surgery
Sydney, New South Wales, Australia
Centre For Eye Research Australia
East Melbourne, Victoria, Australia
Retina Specialists Victoria
Rowville, Victoria, Australia
Centrum Medyczne Julianow; Zeglarska
?ód?, , Poland
Gabinet Okulistyczny Prof Edward Wylegala
Katowice, , Poland
Centrum Medyczne UNO-MED
Krakow, , Poland
Centrum Diagnostyki i Mikrochirurgii Oka LENS
Olsztyn, , Poland
LensClinic
Rybnik, , Poland
Emanuelli Research and Development Center LLC
Arecibo, , Puerto Rico
Fakultna nemocnica s poliklinikou F.D. Roosevelta
Banská Bystrica, , Slovakia
Klinika Oftalmológie LFUK a UNB
Bratislava, , Slovakia
O?ná klinika UNB a SZU
Bratislava, , Slovakia
3F s.r.o
Košice, , Slovakia
Fakultna nemocnica Trencin
Trenčín, , Slovakia
Fakultna nemocnica s poliklinikou Zilina; Ocne oddelenie
Žilina, , Slovakia
Hospital Universitari de Bellvitge; Servicio de Oftalmologia
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital General de Catalunya
San Cugat Del Valles, Barcelona, Spain
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid, Spain
Hospital Dos de Maig
Barcelona, , Spain
Hospital Clinic I Provincial
Barcelona, , Spain
Clinica Barraquer
Barcelona, , Spain
Pio del Rio Hortega University Hospital
Valladolid, , Spain
Miguel Servet University Hospital
Zaragoza, , Spain
Royal Victoria Hospital; Outpatients Department
Belfast, , United Kingdom
Colchester General Hospital
Colchester, Essex, , United Kingdom
Royal Surrey County Hospital; Eye Clinic Research office
Guildford, , United Kingdom
Hull University Teaching Hospitals NHS Trust
Hull, , United Kingdom
Royal Liverpool University Hospital
Liverpool, , United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham, , United Kingdom
Sunderland Eye Infirmary
Sunderland, , United Kingdom
Countries
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References
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Armendariz BG, Luhman UFO, Berger B, Hernandez-Sanchez J, Bogman K, Mitrousis N, Wollenhaupt M, Kent D, Wenzel A, Fauser S. CANBERRA: A Phase II Randomized Clinical Trial to Test the Therapeutic Potential of Oral Vicasinabin in Diabetic Retinopathy. Ophthalmol Sci. 2024 Nov 8;5(2):100650. doi: 10.1016/j.xops.2024.100650. eCollection 2025 Mar-Apr.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2019-002067-10
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
BP41321
Identifier Type: -
Identifier Source: org_study_id
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