A Study to Investigate RO7200220 as Monotherapy and in Combination With Ranibizumab in Participants With Diabetic and Uveitic Macular Edema
NCT ID: NCT06771271
Last Updated: 2025-01-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
85 participants
INTERVENTIONAL
2019-07-22
2023-11-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Part 1: RO7200220 Monotherapy
Participants with DME received multiple ascending doses of RO7200220 (two doses at the assigned dose level), as intravitreal (IVT) injection, every 6 weeks (Q6W) in multiple cohorts.
RO7200220
RO7200220 was administered as IVT injection.
Part 2: Expansion of RO7200220 Monotherapy
Participants with DME who were anti-VEGF and corticosteroid IVT treatment-naive received three doses of RO7200220 monotherapy, as IVT injection, every 4 weeks (Q4W) in Part 2 cohorts.
RO7200220
RO7200220 was administered as IVT injection.
Part 3: RO7200220 in Combination with Ranibizumab
Participants with DME received RO7200220 as IVT injection followed by ranibizumab, 0.5 milligrams (mg) as IVT injection in Part 3.
RO7200220
RO7200220 was administered as IVT injection.
Ranibizumab
Ranibizumab was administered as IVT injection.
Part 4: RO7200220 Monotherapy
Participants with UME received multiple doses of RO7200220 (three doses at the assigned dose level), as IVT injection, Q4W in multiple cohorts.
RO7200220
RO7200220 was administered as IVT injection.
Interventions
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RO7200220
RO7200220 was administered as IVT injection.
Ranibizumab
Ranibizumab was administered as IVT injection.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosis of Diabetes Mellitus (DM) (Type 1 or Type 2), as defined by the World Health Organization and/or American Diabetes Association
* Macular edema associated with DR defined as macular thickening by spectral domain optical coherence tomography (SD-OCT) involving the center of the macula: central subfield thickness (CST) of ≥325 μm with Spectralis.
* Decreased visual acuity (VA) attributable primarily to DME, with BCVA letter score of 73 to 19 letters (both inclusive) on Early Treatment Diabetic Retinopathy Study (ETDRS)-like charts (20/40 -20/400 Snellen equivalent).
* Clear ocular media and adequate pupillary dilation to allow acquisition of good quality retinal images to confirm diagnosis.
UME Participants:
* Diagnosis of noninfectious uveitis (NIU) of any anatomical type (anterior, intermediate, posterior, panuveitis). Active and inactive NIU is allowed.
* Macular edema associated with NIU defined as macular thickening by SD-OCT involving the center of the macula: CST of ≥325 μm with Spectralis.
* Decreased VA attributable primarily to UME, with BCVA letter score of 78 to 19 letters (both inclusive) on ETDRS-like charts (20/32 - 20/400 Snellen equivalent).
* Sufficiently clear ocular media and adequate pupillary dilation to allow acquisition of good quality retinal images to confirm diagnosis.
* Either treatment naive or previously treated in the study eye or systematically (with washout periods and maximum doses applicable for specific treatments).
Exclusion Criteria
* Any febrile illness within 1 week prior to screening or Day 1
* Any stroke or myocardial infarction within 12 months prior to Day 1
* Any active proliferative DR (DME participants only)
* Panretinal photocoagulation or macular laser photocoagulation treatment prior to Day 1
* History of vitreoretinal surgery/pars plana vitrectomy
* Any cataract surgery within 3 months prior to Day 1 or any planned surgery during the study
* History of any glaucoma surgery including laser glaucoma procedures
* Uncontrolled glaucoma
* History of rubeosis iridis
* Any active ocular or periocular infection on Day 1
* Any presence of active intraocular inflammation on Day 1 or any history of intraocular inflammation (DME participants only)
* Any prior or concomitant periocular or IVT corticosteroids in the study eye (DME treatment naive participants only)
* Use of any systemic corticosteroids within 1 month prior to Day 1 (stable oral prednisone for UME participants allowed)
* Any prior or concomitant systemic anti-VEGF treatment within 6 months prior to Day 1
* Any concurrent use of biologics for immune-related diseases
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Retina-Vitreous Associates Medical Group
Beverly Hills, California, United States
California Retina Consultants
Oxnard, California, United States
Retina Institute of California Medical Group d/b/a Acuity Eye Group
Palm Desert, California, United States
Byers Eye Insitute at Stanford
Palo Alto, California, United States
Florida Eye Associates
Melbourne, Florida, United States
Retina Vitreous Assoc of FL
St. Petersburg, Florida, United States
Illinois Retina Associates SC
Oak Park, Illinois, United States
Cumberland Valley Retina PC
Hagerstown, Maryland, United States
Sierra Eye Associates
Reno, Nevada, United States
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Oregon HSU
Portland, Oregon, United States
Mid Atlantic Retina
Philadelphia, Pennsylvania, United States
Retina Res Institute of Texas
Abilene, Texas, United States
Austin Clinical Research LLC
Austin, Texas, United States
Valley Retina Institute P.A.
McAllen, Texas, United States
Medical Center Ophthalmology Associates
San Antonio, Texas, United States
Univ of Virginia Ophthalmology
Charlottesville, Virginia, United States
Karalis Johnson Retina Center
Seattle, Washington, United States
Countries
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Other Identifiers
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BP40899
Identifier Type: -
Identifier Source: org_study_id
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