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

NCT06771271

CompletedPhase 1

Sponsor: Hoffmann-La Roche

Conditions: Diabetic Macular Edema, Uveitic Macular Edema

Interventions: RO7200220, Ranibizumab

Countries: United States

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).

Eligibility overview

Sex: ALL

Age: 18 Years to

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

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).

Exclusion Criteria:

* 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
Locations (19)
  • Beverly Hills, California, United States
  • Oxnard, California, United States
  • Palm Desert, California, United States
  • Palo Alto, California, United States
  • Melbourne, Florida, United States
  • St. Petersburg, Florida, United States
  • Oak Park, Illinois, United States
  • Hagerstown, Maryland, United States
  • Reno, Nevada, United States
  • Winston-Salem, North Carolina, United States
  • Cleveland, Ohio, United States
  • Portland, Oregon, United States
  • Philadelphia, Pennsylvania, United States
  • Abilene, Texas, United States
  • Austin, Texas, United States
  • McAllen, Texas, United States
  • San Antonio, Texas, United States
  • Charlottesville, Virginia, United States
  • Seattle, Washington, United States