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

Completed · Phase 2 · Has a placebo group

Conditions studied: Diabetic Retinopathy

In brief

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.

Key facts

Study ID

NCT04265261

Run by

Hoffmann-La Roche

People needed

139

Starts

2020-06-05

Expected to finish

2023-07-19

Last updated by the study team

2024-09-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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
• Arizona Retina and Vitreous Consultants — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.