Clinical trial NCT04265261: 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
Official title: A Randomized, Double-Masked, 48-Week, Parallel-Group, Placebo-Controlled, Proof-of-Concept Study to Investigate the Efficacy and Safety of RG7774 in Patients With Diabetes Mellitus Type 1 or Type 2 With Treatment-Naive Diabetic Retinopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetic Retinopathy
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2020-02-11
Enrollment: 139
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study's main purpose is to asses the safety, tolerability, and effect of oral administration of RG7774 on the severity of diabetic retinopathy (DR) in participants with moderately severe to severe non-proliferative diabetic retinopathy (NPDR) and good vision.


Eligibility criteria: Inclusion Criteria

* Able and willing to provide written informed consent and to comply with the study protocol according to International Conference of Harmonization (ICH) and local regulations
* 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

Ocular criteria for study eye:

* 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

Primary outcomes:
measure: Proportion of Participants With >/= 2-Step Improvement in the Early Treatment Diabetic Retinopathy Study (ETDRS) DR Severity Scale (DRSS) From Baseline at Week 36 Measured in the Study Eye
timeFrame: Week 36
measure: Percentage of Participants With Adverse Events (AEs)
timeFrame: Up to 1 year (baseline through follow-up period)
Secondary outcomes:
measure: Time-to-Event for Vision-Threatening DR in the Study Eye
timeFrame: Up to Day 277
measure: Incidence of New Anterior Segment Neovascularization (ASNV), New Proliferative Diabetic Retinopathy (PDR), New Diabetic Macular Edema (DME), and Pre-Existing DME Requiring Intervention in the Study Eye
timeFrame: Week 36
measure: Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye at Week 36
timeFrame: Baseline; Week 36
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Retina and Vitreous Consultants
state: Arizona
city: Tucson
country: United States
facility: Retina Associates Tucson
state: Arizona
city: Arcadia
country: United States
facility: Win Retina
state: California
city: Glendale
country: United States
facility: Global Research Management
state: California
city: Torrance
country: United States
facility: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
state: California
city: Colorado Springs
country: United States
facility: Retina Consultants of Southern Colorado PC
state: Colorado
city: Waterford
country: United States
facility: Retina Group of New England
state: Connecticut
city: Deerfield Beach
country: United States
facility: Rand Eye
state: Florida
city: Lakeland
country: United States
facility: Florida Retina Consultants
state: Florida
city: Melbourne
country: United States
facility: Florida Eye Associates
state: Florida
city: Miami
country: United States
facility: Medeye Associates
state: Florida
city: Pensacola
country: United States
facility: Retina Specialty Institute
state: Florida
city: Saint Petersburg
country: United States
facility: Retina Vitreous Assoc of FL
state: Florida
city: Augusta
country: United States
facility: Southeast Retina Center
state: Georgia
city: Marietta
country: United States
facility: Marietta Eye Clinic
state: Georgia
city: Elmhurst
country: United States
facility: Retina Associated Ltd
state: Illinois
city: Oak Forest
country: United States
facility: University Retina and Macula Associates, PC
state: Illinois
city: Hagerstown
country: United States
facility: Cumberland Valley Retina PC
state: Maryland
city: Ann Arbor
country: United States
facility: University of Michigan, Kellogg Eye Center
state: Michigan
city: Southaven
country: United States
facility: Deep Blue Retina PLLC
state: Mississippi
city: Reno
country: United States
facility: Sierra Eye Associates
state: Nevada
city: Bloomfield
country: United States
facility: Envision Ocular, LLC
state: New Jersey
city: Albuquerque
country: United States
facility: Eye Associates of New Mexico
state: New Mexico
city: East Syracuse
country: United States
facility: Velocity Clinical Research
state: New York
city: Oceanside
country: United States
facility: Ophthalmic Consultants of Long Island
state: New York
city: Charlotte
country: United States
facility: Charlotte Eye Ear Nose and Throat Associates
state: North Carolina
city: Portland
country: United States
facility: EyeHealth Northwest
state: Oregon
city: Erie
country: United States
facility: Erie Retinal Surgery
state: Pennsylvania
city: Ladson
country: United States
facility: Charleston Neuroscience Institute
state: South Carolina
city: Chattanooga
country: United States
facility: Southeastern Retina Associates Chattanooga
state: Tennessee
city: Germantown
country: United States
facility: Charles Retina Institute
state: Tennessee
city: Abilene
country: United States
facility: Retina Res Institute of Texas
state: Texas
city: Austin
country: United States
facility: Austin Clinical Research LLC
state: Texas
city: San Antonio
country: United States
facility: San Antonio Eye Center
state: Texas
city: The Woodlands
country: United States
facility: Retina Consultants of Texas
state: Texas
city: The Woodlands
country: United States
facility: Retinal Consultants of Houston
state: Texas
city: Willow Park
country: United States
facility: Strategic Clinical Research Group, LLC
state: Texas
city: Sydney
country: Australia
facility: Sydney Eye Hospital
state: New South Wales
city: Sydney
country: Australia
facility: Sydney Retina Clinic and Day Surgery
state: New South Wales
city: East Melbourne
country: Australia
facility: Centre For Eye Research Australia
state: Victoria
city: Rowville
country: Australia
facility: Retina Specialists Victoria
state: Victoria
city: ?ód?
country: Poland
facility: Centrum Medyczne Julianow; Zeglarska
city: Katowice
country: Poland
facility: Gabinet Okulistyczny Prof Edward Wylegala
city: Krakow
country: Poland
facility: Centrum Medyczne UNO-MED
city: Olsztyn
country: Poland
facility: Centrum Diagnostyki i Mikrochirurgii Oka LENS
city: Rybnik
country: Poland
facility: LensClinic
city: Arecibo
country: Puerto Rico
facility: Emanuelli Research and Development Center LLC
city: Banska Bystrica
country: Slovakia
facility: Fakultna nemocnica s poliklinikou F.D. Roosevelta
city: Bratislava
country: Slovakia
facility: Klinika Oftalmológie LFUK a UNB
city: Bratislava
country: Slovakia
facility: O?ná klinika UNB a SZU
city: Košice
country: Slovakia
facility: 3F s.r.o
city: Trencin
country: Slovakia
facility: Fakultna nemocnica Trencin
city: Zilina
country: Slovakia
facility: Fakultna nemocnica s poliklinikou Zilina; Ocne oddelenie
city: Hospitalet De Llobregat
country: Spain
facility: Hospital Universitari de Bellvitge; Servicio de Oftalmologia
state: Barcelona
city: San Cugat Del Valles
country: Spain
facility: Hospital General de Catalunya
state: Barcelona
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro
state: Madrid
city: Barcelona
country: Spain
facility: Hospital Dos de Maig
city: Barcelona
country: Spain
facility: Hospital Clinic I Provincial
city: Barcelona
country: Spain
facility: Clinica Barraquer
city: Valladolid
country: Spain
facility: Pio del Rio Hortega University Hospital
city: Zaragoza
country: Spain
facility: Miguel Servet University Hospital
city: Belfast
country: United Kingdom
facility: Royal Victoria Hospital; Outpatients Department
city: Colchester, Essex
country: United Kingdom
facility: Colchester General Hospital
city: Guilford
country: United Kingdom
facility: Royal Surrey County Hospital; Eye Clinic Research office
city: Hull
country: United Kingdom
facility: Hull University Teaching Hospitals NHS Trust
city: Liverpool
country: United Kingdom
facility: Royal Liverpool University Hospital
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals NHS Trust
city: Sunderland
country: United Kingdom
facility: Sunderland Eye Infirmary
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: