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

Part of paid clinical trials in Beverly Hills, California.

Sponsor
Hoffmann-La Roche
Study ID
NCT06771271
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • RO7200220 — DRUG
    RO7200220 was administered as IVT injection.
  • Ranibizumab — DRUG
    Ranibizumab was administered as IVT injection.

Study Details

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 Dates

First listed
Jan 13, 2025
Start date
Jul 22, 2019
Status verified
Jan 2025
Primary completion
Nov 13, 2023
Completion
Nov 13, 2023

Study Design

Enrollment
85 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: 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.
  • Experimental: 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.
  • Experimental: 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.
  • Experimental: 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.

Primary Outcome Measure

Part 1: Number of Participants With Adverse Events (AEs) [ Time Frame: Up to 18 weeks ]

Locations (19)

FacilityCityStateZIPSite coordinators
Retina-Vitreous Associates Medical GroupBeverly HillsCalifornia90211-
California Retina ConsultantsOxnardCalifornia93036-
Retina Institute of California Medical Group d/b/a Acuity Eye GroupPalm DesertCalifornia92260-
Byers Eye Insitute at StanfordPalo AltoCalifornia94303-
Florida Eye AssociatesMelbourneFlorida32901-
Retina Vitreous Assoc of FLSt. PetersburgFlorida33711-
Illinois Retina Associates SCOak ParkIllinois60304-
Cumberland Valley Retina PCHagerstownMaryland21740-
Sierra Eye AssociatesRenoNevada89502-
Wake Forest Baptist Medical CenterWinston-SalemNorth Carolina27157-
Cleveland Clinic FoundationClevelandOhio44195-
Oregon HSUPortlandOregon97239-
Mid Atlantic RetinaPhiladelphiaPennsylvania19107-
Retina Res Institute of TexasAbileneTexas79606-
Austin Clinical Research LLCAustinTexas78750-
Valley Retina Institute P.A.McAllenTexas78503-
Medical Center Ophthalmology AssociatesSan AntonioTexas78240-
Univ of Virginia OphthalmologyCharlottesvilleVirginia22903-
Karalis Johnson Retina CenterSeattleWashington98109-

Find similar trials in Beverly Hills, CA

By condition
Diabetic retinopathy
By specialty
OphthalmologyRetina
By research site
Retina-Vitreous Associates Medical Group· Beverly Hills, CACalifornia Retina Consultants· Oxnard, CARetina Institute of California Medical Group d/b/a Acuity Eye Group· Palm Desert, CAByers Eye Insitute at Stanford· Palo Alto, CAFlorida Eye Associates· Melbourne, FLRetina Vitreous Assoc of FL· St. Petersburg, FL

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