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Trial record 1 of 1 for:    GR42163
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A Study Evaluating the Safety, Tolerability, Pharmacokinetics and Immunogenicity of Intravitreal Injections of RO7303359 in Participants With Geographic Atrophy

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04615325
Recruitment Status : Recruiting
First Posted : November 4, 2020
Last Update Posted : September 22, 2022
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This multicenter study will investigate the safety, tolerability, pharmacokinetics, and immunogenicity of RO7303359 following single Intravitreal (ITV) injection in participants with geographic atrophy (GA) secondary to age related macular degeneration (AMD). The participants will receive ITV injections of RO7303359 in the single ascending dose stage and maximum tolerated dose (MTD) or maximum tested dose (MTeD) of RO7303359 will be administered in the expansion stage.

Condition or disease Intervention/treatment Phase
Geographic Atrophy Drug: RO7303359 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 63 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1a, Multicenter, Open Label, Single Dose, Dose Escalation Study of the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Intravitreal Injections of RO7303359 in Patients With Geographic Atrophy Secondary to Age Related Macular Degeneration
Actual Study Start Date : December 8, 2020
Estimated Primary Completion Date : January 1, 2023
Estimated Study Completion Date : January 1, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Single ascending dose stage
Patients will receive a single dose of RO7303359, in multiple escalating cohorts (A-D)
Drug: RO7303359
RO730359 will be administered at a single intravitreal injection

Experimental: Expansion cohort stage
Participants will receive the maximum tolerated dose (MTD) or the maximum tested dose (MTeD) as determined in the single ascending dose stage.
Drug: RO7303359
RO730359 will be administered at a single intravitreal injection

Experimental: Optional cohort E
An optional additional cohort maybe added with the dose not exceed the MTD or MTeD
Drug: RO7303359
RO730359 will be administered at a single intravitreal injection

Experimental: Optional cohort F
An optional additional cohort maybe added with the dose not exceed the MTD or MTeD
Drug: RO7303359
RO730359 will be administered at a single intravitreal injection




Primary Outcome Measures :
  1. Proportion of participants with Adverse Events and Serious Adverse Events [ Time Frame: Up to 12 Weeks ]
    Adverse events will be determined by the World Health Organization toxicity grading scale

  2. Proportion of participants with changes in best corrected visual acuity (BCVA) following RO7303359 administration [ Time Frame: Up to 12 Weeks ]

Secondary Outcome Measures :
  1. Serum concentration of RO7303359 [ Time Frame: Up to 12 Weeks ]
  2. Aqueous humor concentration of RO7303359 [ Time Frame: Up to 12 Weeks ]
  3. Concentration of serum anti drug antibodies (ADAs) at baseline and incidence of serum ADAs [ Time Frame: Up to 12 Weeks ]
  4. Proportion of participants with anti-drug-antibodies (ADA) to RO7303359 [ Time Frame: Up to 12 Weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Ocular Inclusion Criteria Study Eye:

  • Well-demarcated area of GA secondary to AMD in the absence of choroidal neovascularization (CNV)
  • GA area must be >= 0.5 disc area (1.25 mm2)

Ocular Exclusion Criteria, Study eye:

  • GA due to causes other than AMD
  • History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD
  • Previous laser photocoagulation for CNV, diabetic macular edema, retinal vein occlusion, or proliferative diabetic retinopathy
  • Prior treatment with Visudyne, external beam radiation therapy (for intraocular conditions), or transpupillary thermotherapy

Ocular Exclusion Criteria, Both eyes:

  • Evidence of prior or active CNV
  • Previous participation in interventional clinical trials for GA or dry AMD, except for vitamins and minerals, irrespective of the route of administration (i.e. ocular or systemic) within the last 6 months

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): NCT04615325


Contacts
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Contact: Reference Study ID Number: GR42163 https://forpatients.roche.com/ 888-662-6728 (U.S. and Canada) global-roche-genentech-trials@gene.com

Locations
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United States, California
The Retina Partners Recruiting
Encino, California, United States, 91436
Northern California Retina Vitreous Associates Recruiting
Mountain View, California, United States, 94040
Retinal Consultants Med Group Recruiting
Sacramento, California, United States, 95825
California Retina Consultants - Santa Maria Recruiting
Santa Maria, California, United States, 93454
United States, Colorado
Colorado Retina Associates, PC Recruiting
Denver, Colorado, United States, 80230
United States, Florida
Florida Eye Associates Recruiting
Melbourne, Florida, United States, 32901
United States, Illinois
University Retina and Macula Associates, PC Recruiting
Lemont, Illinois, United States, 60439
United States, Michigan
Associated Retinal Consultants PC Recruiting
Royal Oak, Michigan, United States, 48073
United States, Nevada
Sierra Eye Associates Recruiting
Reno, Nevada, United States, 89502
United States, North Carolina
Western Carolina Retinal Associate PA Recruiting
Asheville, North Carolina, United States, 28803
United States, Tennessee
Tennessee Retina PC. Recruiting
Nashville, Tennessee, United States, 37203
United States, Texas
Austin Clinical Research LLC Recruiting
Austin, Texas, United States, 78750
Retina Foundation of the Southwest Recruiting
Dallas, Texas, United States, 75231
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT04615325    
Other Study ID Numbers: GR42163
First Posted: November 4, 2020    Key Record Dates
Last Update Posted: September 22, 2022
Last Verified: September 2022
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).
Supporting Materials: Study Protocol

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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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Geographic Atrophy
Atrophy
Pathological Conditions, Anatomical
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases