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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-002067-10 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Placebo Comparator | Participants will receive an oral dose of placebo matched to RG7774 once daily (QD) |
|
| Group B | Experimental | Participants will receive a low oral dose of RG7774 QD |
|
| Group C | Experimental | Participants will receive a high oral dose of RG7774 QD |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Participants will receive oral placebo matched to RG7774 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | The ETDRS DRSS is a standardized grading test to measure diabetic retinopathy progression, where higher scores indicate a higher risk of vision loss. The DRSS ranges from level 10 (no diabetic retinopathy) to level 85 (advanced diabetic retinopathy) | Week 36 |
| Percentage of Participants With Adverse Events (AEs) | Up to 1 year (baseline through follow-up period) |
| Measure | Description | Time Frame |
|---|---|---|
| Time-to-Event for Vision-Threatening DR in the Study Eye | Vision-threatening DR was defined as anterior segment neovascularization (ASNV), new proliferative diabetic retinopathy (PDR), new diabetic macular edema (DME), and pre-existing DME requiring treatment. Time-to-event was defined as the time where 50% of the population develops a DR vision-threatening event. | Up to Day 277 |
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Inclusion Criteria
Exclusion Criteria
Ocular criteria for study eye:
Concurrent ocular conditions in either eye:
General Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Retina and Vitreous Consultants | Phoenix | Arizona | 85016 | United States | ||
| Retina Associates Tucson |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39802207 | Derived | 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. |
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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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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received an oral dose of placebo matched to RG7774 once daily (QD) |
| FG001 | Vicasinabin 30 mg QD | Participants received 30 mg of oral RG7774 QD |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 4, 2021 |
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| RG7774 |
| Drug |
Participants will receive oral RG7774 |
|
| 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 | This is a descriptive summary of the incidence of new ASNV, new PDR, new DME, and pre-existing DME, all of which indicate disease progression. Each row presents the proportion of participants amongst the overall population for each event. | Week 36 |
| Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye at Week 36 | BCVA was measured by a qualified VA examiner prior to pupil dilation using modified ETDRS Charts 1, 2, and R. The adjusted mean is reported for each group. | Baseline; Week 36 |
| Tucson |
| Arizona |
| 85710 |
| United States |
| Win Retina | Arcadia | California | 91006 | United States |
| Global Research Management | Glendale | California | 91204 | United States |
| Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center | Torrance | California | 90502 | United States |
| Retina Consultants of Southern Colorado PC | Colorado Springs | Colorado | 80909 | United States |
| Retina Group of New England | Waterford | Connecticut | 06385 | United States |
| Rand Eye | Deerfield Beach | Florida | 33064 | United States |
| Florida Retina Consultants | Lakeland | Florida | 33805 | United States |
| Florida Eye Associates | Melbourne | Florida | 32901 | United States |
| Medeye Associates | Miami | Florida | 33143 | United States |
| Retina Specialty Institute | Pensacola | Florida | 32503 | United States |
| Retina Vitreous Assoc of FL | St. Petersburg | Florida | 33711 | United States |
| Southeast Retina Center | Augusta | Georgia | 30909 | United States |
| Marietta Eye Clinic | Marietta | Georgia | 30060 | United States |
| Retina Associated Ltd | Elmhurst | Illinois | 60126 | United States |
| University Retina and Macula Associates, PC | Oak Forest | Illinois | 60452 | United States |
| Cumberland Valley Retina PC | Hagerstown | Maryland | 21740 | United States |
| University of Michigan, Kellogg Eye Center | Ann Arbor | Michigan | 48105 | United States |
| Deep Blue Retina PLLC | Southaven | Mississippi | 38671 | United States |
| Sierra Eye Associates | Reno | Nevada | 89502 | United States |
| Envision Ocular, LLC | Bloomfield | New Jersey | 07003 | United States |
| Eye Associates of New Mexico | Albuquerque | New Mexico | 87109 | United States |
| Velocity Clinical Research | East Syracuse | New York | 13057 | United States |
| Ophthalmic Consultants of Long Island | Oceanside | New York | 11572 | United States |
| Charlotte Eye Ear Nose and Throat Associates | Charlotte | North Carolina | 28210 | United States |
| EyeHealth Northwest | Portland | Oregon | 97225 | United States |
| Erie Retinal Surgery | Erie | Pennsylvania | 16507 | United States |
| Charleston Neuroscience Institute | Ladson | South Carolina | 29456 | United States |
| Southeastern Retina Associates Chattanooga | Chattanooga | Tennessee | 37421 | United States |
| Charles Retina Institute | Germantown | Tennessee | 38138 | United States |
| Retina Res Institute of Texas | Abilene | Texas | 79606 | United States |
| Austin Clinical Research LLC | Austin | Texas | 78750 | United States |
| San Antonio Eye Center | San Antonio | Texas | 78215 | United States |
| Retina Consultants of Texas | The Woodlands | Texas | 77384-4167 | United States |
| Retinal Consultants of Houston | The Woodlands | Texas | 77384 | United States |
| Strategic Clinical Research Group, LLC | Willow Park | Texas | 76087 | United States |
| Sydney Eye Hospital | Sydney | New South Wales | 2000 | Australia |
| Sydney Retina Clinic and Day Surgery | Sydney | New South Wales | 2000 | Australia |
| Centre For Eye Research Australia | East Melbourne | Victoria | 3002 | Australia |
| Retina Specialists Victoria | Rowville | Victoria | 3178 | Australia |
| Centrum Medyczne Julianow; Zeglarska | ?ód? | 91-321 | Poland |
| Gabinet Okulistyczny Prof Edward Wylegala | Katowice | 40-594 | Poland |
| Centrum Medyczne UNO-MED | Krakow | 31-070 | Poland |
| Centrum Diagnostyki i Mikrochirurgii Oka LENS | Olsztyn | 10-424 | Poland |
| LensClinic | Rybnik | 44-203 | Poland |
| Emanuelli Research and Development Center LLC | Arecibo | 00612 | Puerto Rico |
| Fakultna nemocnica s poliklinikou F.D. Roosevelta | Banská Bystrica | 974 01 | Slovakia |
| Klinika Oftalmológie LFUK a UNB | Bratislava | 826 06 | Slovakia |
| O?ná klinika UNB a SZU | Bratislava | 851 07 | Slovakia |
| 3F s.r.o | Košice | 040 11 | Slovakia |
| Fakultna nemocnica Trencin | Trenčín | 911 71 | Slovakia |
| Fakultna nemocnica s poliklinikou Zilina; Ocne oddelenie | Žilina | 012 07 | Slovakia |
| Hospital Universitari de Bellvitge; Servicio de Oftalmologia | L'Hospitalet de Llobregat | Barcelona | 8907 | Spain |
| Hospital General de Catalunya | San Cugat Del Valles | Barcelona | 08195 | Spain |
| Hospital Universitario Puerta de Hierro | Majadahonda | Madrid | 28222 | Spain |
| Hospital Dos de Maig | Barcelona | 08025 | Spain |
| Hospital Clinic I Provincial | Barcelona | 08036 | Spain |
| Clinica Barraquer | Barcelona | 8021 | Spain |
| Pio del Rio Hortega University Hospital | Valladolid | 47012 | Spain |
| Miguel Servet University Hospital | Zaragoza | 50009 | Spain |
| Royal Victoria Hospital; Outpatients Department | Belfast | BT12 6BA | United Kingdom |
| Colchester General Hospital | Colchester, Essex | CO4 5JL | United Kingdom |
| Royal Surrey County Hospital; Eye Clinic Research office | Guildford | GU2 7XX | United Kingdom |
| Hull University Teaching Hospitals NHS Trust | Hull | HU3 2JZ | United Kingdom |
| Royal Liverpool University Hospital | Liverpool | L7 8XP | United Kingdom |
| Nottingham University Hospitals NHS Trust | Nottingham | NG7 2UH | United Kingdom |
| Sunderland Eye Infirmary | Sunderland | SR2 9HP | United Kingdom |
| FG002 | Vicasinabin 200 mg QD | Participants received 200 mg of oral RG7774 QD |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received an oral dose of placebo matched to RG7774 once daily (QD) |
| BG001 | Vicasinabin 30 mg QD | Participants received 30 mg of oral RG7774 QD |
| BG002 | Vicasinabin 200 mg QD | Participants received 200 mg of oral RG7774 QD |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | The ETDRS DRSS is a standardized grading test to measure diabetic retinopathy progression, where higher scores indicate a higher risk of vision loss. The DRSS ranges from level 10 (no diabetic retinopathy) to level 85 (advanced diabetic retinopathy) | The mITT population is defined as all participants who give informed consent, are randomized, and receive at least one dose of study treatment (active or placebo). For the mITT population, data were analyzed according to the treatment participants were randomized to. | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 36 |
|
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| Secondary | Time-to-Event for Vision-Threatening DR in the Study Eye | Vision-threatening DR was defined as anterior segment neovascularization (ASNV), new proliferative diabetic retinopathy (PDR), new diabetic macular edema (DME), and pre-existing DME requiring treatment. Time-to-event was defined as the time where 50% of the population develops a DR vision-threatening event. | The mITT population is defined as all participants who give informed consent, are randomized, and receive at least one dose of study treatment (active or placebo). For the mITT population, data were analyzed according to the treatment participants were randomized to. | Posted | Number | 95% Confidence Interval | Days | Up to Day 277 |
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| Secondary | 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 | This is a descriptive summary of the incidence of new ASNV, new PDR, new DME, and pre-existing DME, all of which indicate disease progression. Each row presents the proportion of participants amongst the overall population for each event. | The mITT population is defined as all participants who give informed consent, are randomized, and receive at least one dose of study treatment (active or placebo). For the mITT population, data were analyzed according to the treatment participants were randomized to. | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 36 |
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| Secondary | Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye at Week 36 | BCVA was measured by a qualified VA examiner prior to pupil dilation using modified ETDRS Charts 1, 2, and R. The adjusted mean is reported for each group. | The mITT population is defined as all participants who give informed consent, are randomized, and receive at least one dose of study treatment (active or placebo). For the mITT population, data were analyzed according to the treatment participants were randomized to. | Posted | Mean | Standard Error | Number of letters | Baseline; Week 36 |
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| Primary | Percentage of Participants With Adverse Events (AEs) | The Safety population is defined as all participants who give informed consent, receive at least one dose of study medication (active or placebo) and were grouped according to the actual treatment received. | Posted | Number | Percentage of participants | Up to 1 year (baseline through follow-up period) |
|
|
Up to 1 year (baseline through follow-up period)
All-cause mortality includes the entire study population. SAE and NSAE reporting includes the safety population, which included all participants who gave informed consent and received at least one dose of study medication. Participants in the safety population were grouped according to the actual treatment received.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Participants received an oral dose of placebo matched to RG7774 once daily (QD) | 1 | 47 | 8 | 47 | 13 | 47 |
| EG001 | Vicasinabin 30 mg QD | Participants received 30 mg of oral RG7774 QD | 0 | 48 | 3 | 48 | 21 | 48 |
| EG002 | Vicasinabin 200 mg QD | Participants received 200 mg of oral RG7774 QD | 0 | 44 | 5 | 43 | 15 | 43 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrioventricular block second degree | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Diabetic retinopathy | Eye disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Retinal tear | Eye disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Biliary colic | Hepatobiliary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Extradural abscess | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Endometrial hyperplasia | Reproductive system and breast disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Intermittent claudication | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diabetic retinal oedema | Eye disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Diabetic retinopathy | Eye disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Vitreous haemorrhage | Eye disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
|
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 1-800-821-8590 | genentech@druginfo.com |
| Jul 16, 2024 |
| Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003930 | Diabetic Retinopathy |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
|
| Risk Difference (RD) |
| -2.93 |
| 2-Sided |
| 95 |
| -15.18 |
| 9.31 |
| Superiority |
| Units |
|---|
| Counts |
|---|
| Participants |
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| Units | Counts |
|---|---|
| Participants |
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| Participants |
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