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

Diabetic Retinopathy Clinical Trial

— CANBERRA  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04265261
• Other study ID #: BP41321
• Secondary ID: 2019-002067-10
• Status: Completed
• Phase: Phase 2
• Start date: June 5, 2020
• Est. completion date: July 19, 2023

Study information

• Verified date: January 2024
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: July 19, 2023
• Est. primary completion date: July 19, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Diabetic Retinopathy
• Retinal Diseases

Intervention

Drug:
• Placebo
Participants will receive oral placebo matched to RG7774
• RG7774
Participants will receive oral RG7774

Locations

Country	Name	City	State
Australia	Centre For Eye Research Australia	East Melbourne	Victoria
Australia	Retina Specialists Victoria	Rowville	Victoria
Australia	Sydney Eye Hospital	Sydney	New South Wales
Australia	Sydney Retina Clinic and Day Surgery	Sydney	New South Wales
Poland	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
Puerto Rico	Emanuelli Research and Development Center LLC	Arecibo
Slovakia	Fakultna nemocnica s poliklinikou F.D. Roosevelta	Banska 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	Trencin
Slovakia	Fakultna nemocnica s poliklinikou Zilina; Ocne oddelenie	Zilina
Spain	Clinica Barraquer	Barcelona
Spain	Hospital Clinic I Provincial	Barcelona
Spain	Hospital Dos de Maig	Barcelona
Spain	Hospital Universitari de Bellvitge; Servicio de Oftalmologia	Hospitalet De Llobregat	Barcelona
Spain	Hospital Universitario Puerta de Hierro	Majadahonda	Madrid
Spain	Hospital General de Catalunya	San Cugat Del Valles	Barcelona
Spain	Pio del Rio Hortega University Hospital	Valladolid
Spain	Miguel Servet University Hospital	Zaragoza
United Kingdom	Royal Victoria Hospital; Outpatients Department	Belfast
United Kingdom	Colchester General Hospital	Colchester, Essex
United Kingdom	Royal Surrey County Hospital; Eye Clinic Research office	Guilford
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 States	Retina Res Institute of Texas	Abilene	Texas
United States	Eye Associates of New Mexico	Albuquerque	New Mexico
United States	University of Michigan, Kellogg Eye Center	Ann Arbor	Michigan
United States	Win Retina	Arcadia	California
United States	Southeast Retina Center	Augusta	Georgia
United States	Austin Clinical Research LLC	Austin	Texas
United States	Envision Ocular, LLC	Bloomfield	New Jersey
United States	Charlotte Eye Ear Nose and Throat Associates	Charlotte	North Carolina
United States	Southeastern Retina Associates Chattanooga	Chattanooga	Tennessee
United States	Retina Consultants of Southern Colorado PC	Colorado Springs	Colorado
United States	Rand Eye	Deerfield Beach	Florida
United States	Velocity Clinical Research	East Syracuse	New York
United States	Retina Associated Ltd	Elmhurst	Illinois
United States	Erie Retinal Surgery	Erie	Pennsylvania
United States	Charles Retina Institute	Germantown	Tennessee
United States	Global Research Management	Glendale	California
United States	Cumberland Valley Retina PC	Hagerstown	Maryland
United States	Charleston Neuroscience Institute	Ladson	South Carolina
United States	Florida Retina Consultants	Lakeland	Florida
United States	Marietta Eye Clinic	Marietta	Georgia
United States	Florida Eye Associates	Melbourne	Florida
United States	Medeye Associates	Miami	Florida
United States	University Retina and Macula Associates, PC	Oak Forest	Illinois
United States	Ophthalmic Consultants of Long Island	Oceanside	New York
United States	Retina Specialty Institute	Pensacola	Florida
United States	Arizona Retina and Vitreous Consultants	Phoenix	Arizona
United States	EyeHealth Northwest	Portland	Oregon
United States	Sierra Eye Associates	Reno	Nevada
United States	Retina Vitreous Assoc of FL	Saint Petersburg	Florida
United States	San Antonio Eye Center	San Antonio	Texas
United States	Deep Blue Retina PLLC	Southaven	Mississippi
United States	Retina Consultants of Texas	The Woodlands	Texas
United States	Retinal Consultants of Houston	The Woodlands	Texas
United States	Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center	Torrance	California
United States	Retina Associates Tucson	Tucson	Arizona
United States	Retina Group of New England	Waterford	Connecticut
United States	Strategic Clinical Research Group, LLC	Willow Park	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Australia,  Poland,  Puerto Rico,  Slovakia,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		Week 36
Primary	Percentage of Participants with Adverse Events (AEs)		From baseline up to 52 weeks
Secondary	Percentage of Participants with Anterior Segment Neovascularization (ASNV), new Proliferative Diabetic Retinopathy (PDR), new Diabetic Macular Edema (DME), and Pre-Existing DME Requiring Intervention		From baseline up to 52 weeks
Secondary	Change from Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye		Baseline; Week 36