A Study to Investigate RO7200220 as Monotherapy and in Combination With Ranibizumab in Participants With Diabetic and Uveitic Macular Edema

Completed · Phase 1

Conditions studied: Diabetic Macular Edema, Uveitic Macular Edema

In brief

The purpose of this study was to assess the safety and tolerability of RO7200220 as monotherapy (diabetic macular edema \[DME\] or uveitic macular edema \[UME\] population) and in combination with ranibizumab (DME population only).

Key facts

Study ID

NCT06771271

Run by

Hoffmann-La Roche

People needed

85

Starts

2019-07-22

Expected to finish

2023-11-13

Last updated by the study team

2025-01-13

Who can join

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

You may qualify if…

• DME Participants:
• 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).

You may not qualify if…

• Any major illness or major surgical procedure within 1 month prior to Day 1
• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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