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NCT06771271CompletedPhase 1

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

A Multi-center, Non-Randomized, Open-label, Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO7200220 in Monotherapy and in Combination With Ranibizumab Following Intravitreal Administration in Patients With Diabetic or Uveitic Macular Edema

Source: ClinicalTrials.gov · Last updated 13 Jan 2025

Brief summary (registry, in English)

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).

Status (registry)
Completed
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
85 (actual)
First submitted
8 Jan 2025
Start date
22 Jul 2019
Primary completion date
13 Nov 2023
Lead sponsor
Hoffmann-La Roche
NCT number
NCT06771271

What you commit to

  • Study type: Interventional · Phase 1
  • Participants enrolled: 85
  • From 22 Jul 2019 to the primary completion date, 13 Nov 2023
  • 19 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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
  • Panretinal photocoagulation or macular laser photocoagulation treatment prior to Day 1
  • Any cataract surgery within 3 months prior to Day 1 or any planned surgery during the study
  • 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

Other illness

  • History of vitreoretinal surgery/pars plana vitrectomy
  • History of any glaucoma surgery including laser glaucoma procedures
  • 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)

Other

  • Any active proliferative DR (DME participants only)
  • Uncontrolled glaucoma

Who the study is looking for

  • 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).

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (19)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Retina Res Institute of Texas
Coordinator of this site? Confirm its status
AbileneUnited StatesUnknown status
Austin Clinical Research, LLC
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AustinUnited StatesUnknown status
Retina-Vitreous Associates Medical Group
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Beverly HillsUnited StatesUnknown status
Univ of Virginia Ophthalmology
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CharlottesvilleUnited StatesUnknown status
Cleveland Clinic Foundation
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ClevelandUnited StatesUnknown status
Cumberland Valley Retina PC
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HagerstownUnited StatesUnknown status
Valley Retina Institute P.A.
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McAllenUnited StatesUnknown status
Florida Eye Associates
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MelbourneUnited StatesUnknown status
Illinois Retina Associates SC
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Oak ParkUnited StatesUnknown status
California Retina Consultants
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OxnardUnited StatesUnknown status
Retina Institute of California Medical Group d/b/a Acuity Eye Group
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Palm DesertUnited StatesUnknown status
Byers Eye Insitute at Stanford
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Palo AltoUnited StatesUnknown status
Mid Atlantic Retina
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PhiladelphiaUnited StatesUnknown status
Oregon HSU
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PortlandUnited StatesUnknown status
Sierra Eye Associates
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RenoUnited StatesUnknown status
Medical Center Ophthalmology Associates
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San AntonioUnited StatesUnknown status
Karalis Johnson Retina Center
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SeattleUnited StatesUnknown status
Retina Vitreous Assoc of FL
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St. PetersburgUnited StatesUnknown status
Wake Forest Baptist Medical Center
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Winston-SalemUnited StatesUnknown status

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.