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

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

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).

Study Overview

• Status: Completed
• Conditions: Diabetic Macular Edema; Uveitic Macular Edema
• Intervention / Treatment: Drug: RO7200220; Drug: Ranibizumab

• Study Type: Interventional
• Enrollment (Actual): 85
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Beverly Hills, California, United States, 90211
      • Retina-Vitreous Associates Medical Group
    • Oxnard, California, United States, 93036
      • California Retina Consultants
    • Palm Desert, California, United States, 92260
      • Retina Institute of California Medical Group d/b/a Acuity Eye Group
    • Palo Alto, California, United States, 94303
      • Byers Eye Insitute at Stanford
  • Florida
    • Melbourne, Florida, United States, 32901
      • Florida Eye Associates
    • Saint Petersburg, Florida, United States, 33711
      • Retina Vitreous Assoc of FL
  • Illinois
    • Oak Park, Illinois, United States, 60304
      • Illinois Retina Associates SC
  • Maryland
    • Hagerstown, Maryland, United States, 21740
      • Cumberland Valley Retina PC
  • Nevada
    • Reno, Nevada, United States, 89502
      • Sierra Eye Associates
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest Baptist Medical Center
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Foundation
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon HSU
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Mid Atlantic Retina
  • Texas
    • Abilene, Texas, United States, 79606
      • Retina Res Institute of Texas
    • Austin, Texas, United States, 78750
      • Austin Clinical Research LLC
    • McAllen, Texas, United States, 78503
      • Valley Retina Institute P.A.
    • San Antonio, Texas, United States, 78240
      • Medical Center Ophthalmology Associates
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • Univ of Virginia Ophthalmology
  • Washington
    • Seattle, Washington, United States, 98109
      • Karalis Johnson Retina Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: RO7200220; RO7200220 was administered as IVT injection.; Other Names: Vamikibart
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.	Drug: RO7200220; RO7200220 was administered as IVT injection.; Other Names: Vamikibart
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.	Drug: RO7200220; RO7200220 was administered as IVT injection.; Other Names: Vamikibart; Drug: Ranibizumab; Ranibizumab was administered as IVT injection.
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.	Drug: RO7200220; RO7200220 was administered as IVT injection.; Other Names: Vamikibart

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Part 1: Number of Participants With Adverse Events (AEs)	Up to 18 weeks
Part 2: Number of Participants With Adverse Events (AEs)	Up to 24 weeks
Part 3: Number of Participants With Adverse Events (AEs)	Up to 20 weeks
Part 4: Number of Participants With Adverse Events (AEs)	Up to 36 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Maximum Serum Concentration (Cmax)	Part 1: Up to Week 18; Parts 2: Up to Week 24; Part 3: Up to Week 20; Part 4: Up to Week 36
Minimum Serum Concentration (Ctrough)	Part 1: Up to Week 18; Parts 2: Up to Week 24; Part 3: Up to Week 20; Part 4: Up to Week 36
Time to Peak Serum Concentration (Tmax)	Part 1: Up to Week 18; Parts 2: Up to Week 24; Part 3: Up to Week 20; Part 4: Up to Week 36
Area Under the Concentration-time Curve to the End of Dosing Period (AUC0-t)	Part 1: Up to Week 18; Parts 2: Up to Week 24; Part 3: Up to Week 20; Part 4: Up to Week 36

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche
• Investigators: Study Director: Clinical Trials, Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start (Actual): July 22, 2019
• Primary Completion (Actual): November 13, 2023
• Study Completion (Actual): November 13, 2023

Study Registration Dates

• First Submitted: January 8, 2025
• First Submitted That Met QC Criteria: January 8, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 8, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Diseases; Retinal Degeneration; Macular Degeneration; Edema; Macular Edema; Antineoplastic Agents; Physiological Effects of Drugs; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Ranibizumab
• Other Study ID Numbers: BP40899

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No