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Trial record 1 of 265 for:    CANBERRA
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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 (CANBERRA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04265261
Recruitment Status : Active, not recruiting
First Posted : February 11, 2020
Last Update Posted : March 6, 2023
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Description
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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.

Condition or disease Intervention/treatment Phase
Diabetic Retinopathy Drug: Placebo Drug: RG7774 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : June 5, 2020
Estimated Primary Completion Date : July 18, 2023
Estimated Study Completion Date : July 18, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Group A
Participants will receive an oral dose of placebo matched to RG7774 once daily (QD)
 Drug: Placebo
Participants will receive oral placebo matched to RG7774
Experimental: Group B
Participants will receive a low oral dose of RG7774 QD
 Drug: RG7774
Participants will receive oral RG7774
Experimental: Group C
Participants will receive a high oral dose of RG7774 QD
 Drug: RG7774
Participants will receive oral RG7774


Outcome Measures
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Primary Outcome Measures :
  1. 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 [ Time Frame: Week 36 ]
  2. Percentage of Participants with Adverse Events (AEs) [ Time Frame: From baseline up to 52 weeks ]

Secondary Outcome Measures :
  1. Percentage of Participants with Anterior Segment Neovascularization (ASNV), new Proliferative Diabetic Retinopathy (PDR), new Diabetic Macular Edema (DME), and Pre-Existing DME Requiring Intervention [ Time Frame: From baseline up to 52 weeks ]
  2. Change from Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye [ Time Frame: Baseline; Week 36 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04265261


Locations
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Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
More Information
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT04265261    
Other Study ID Numbers: BP41321
2019-002067-10 ( EudraCT Number )
First Posted: February 11, 2020    Key Record Dates
Last Update Posted: March 6, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Retinal Diseases
Diabetic Retinopathy
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Autoimmune Diseases
Immune System Diseases