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CompletedNCT06771271DOVETAILUpdated Jan 13, 2025

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

A Phase 1 interventional study of RO7200220 and Ranibizumab in Diabetic Macular Edema and Uveitic Macular Edema, sponsored by Hoffmann-La Roche. Completed at 19 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-13.

Sponsored by Hoffmann-La Roche · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Nov 2023, 2 years 11 months ago, and no results have been posted to the registry.
  • Registered 5 years 5 months after the study started (first participant enrolled Jul 2019, registered Jan 2025).
Phase
Phase 1
Study type
Interventional
Enrollment
85
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

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).

02

Conditions studied

  • Diabetic Macular Edema
  • Uveitic Macular Edema
03

In context

Lead sponsor

Hoffmann-La Roche is the lead sponsor of 2,099 studies on the registry; 87 are open to participants now.

Of its 324 completed or terminated interventional studies of FDA-regulated products, 245 (76%) have results posted.

Browse Hoffmann-La Roche studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
85 participants (actual)

Study 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.

    Drug: RO7200220

  • 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

  • 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 · Drug: Ranibizumab

  • 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

Interventions

  • DrugRO7200220

    RO7200220 was administered as IVT injection.

    Also known as: Vamikibart

  • DrugRanibizumab

    Ranibizumab was administered as IVT injection.

06

What researchers measure

Primary outcomes

  1. Part 1: Number of Participants With Adverse Events (AEs)

    Time frame: Up to 18 weeks

  2. Part 2: Number of Participants With Adverse Events (AEs)

    Time frame: Up to 24 weeks

  3. Part 3: Number of Participants With Adverse Events (AEs)

    Time frame: Up to 20 weeks

  4. Part 4: Number of Participants With Adverse Events (AEs)

    Time frame: Up to 36 weeks

Secondary outcomes

  1. Maximum Serum Concentration (Cmax)

    Time frame: Part 1: Up to Week 18; Parts 2: Up to Week 24; Part 3: Up to Week 20; Part 4: Up to Week 36

  2. Minimum Serum Concentration (Ctrough)

    Time frame: Part 1: Up to Week 18; Parts 2: Up to Week 24; Part 3: Up to Week 20; Part 4: Up to Week 36

  3. Time to Peak Serum Concentration (Tmax)

    Time frame: Part 1: Up to Week 18; Parts 2: Up to Week 24; Part 3: Up to Week 20; Part 4: Up to Week 36

  4. Area Under the Concentration-time Curve to the End of Dosing Period (AUC0-t)

    Time frame: Part 1: Up to Week 18; Parts 2: Up to Week 24; Part 3: Up to Week 20; Part 4: Up to Week 36

07

Study locations

19 sites
  • Retina-Vitreous Associates Medical Group
    Beverly Hills, California 90211, United States
  • California Retina Consultants
    Oxnard, California 93036, United States
  • Retina Institute of California Medical Group d/b/a Acuity Eye Group
    Palm Desert, California 92260, United States
  • Byers Eye Insitute at Stanford
    Palo Alto, California 94303, United States
  • Florida Eye Associates
    Melbourne, Florida 32901, United States
  • Retina Vitreous Assoc of FL
    St. Petersburg, Florida 33711, United States
  • Illinois Retina Associates SC
    Oak Park, Illinois 60304, United States
  • Cumberland Valley Retina PC
    Hagerstown, Maryland 21740, United States
  • Sierra Eye Associates
    Reno, Nevada 89502, United States
  • Wake Forest Baptist Medical Center
    Winston-Salem, North Carolina 27157, United States
  • Cleveland Clinic Foundation
    Cleveland, Ohio 44195, United States
  • Oregon HSU
    Portland, Oregon 97239, United States
  • Mid Atlantic Retina
    Philadelphia, Pennsylvania 19107, United States
  • Retina Res Institute of Texas
    Abilene, Texas 79606, United States
  • Austin Clinical Research LLC
    Austin, Texas 78750, United States
  • Valley Retina Institute P.A.
    McAllen, Texas 78503, United States
  • Medical Center Ophthalmology Associates
    San Antonio, Texas 78240, United States
  • Univ of Virginia Ophthalmology
    Charlottesville, Virginia 22903, United States
  • Karalis Johnson Retina Center
    Seattle, Washington 98109, United States
08

References and documents

Publications

  • Sharma S, Lin P, Hu A, Suhler EB, Pauly-Evers M, Holmes W, Barekati Z, Willen D, Macgregor L, Steeples L, Haskova Z, Feenstra D, Silverman D, Passemard B, Fauser S, Mesquida M. Interleukin 6 Inhibition With Vamikibart for Uveitic Macular Edema: The Phase 1 DOVETAIL Nonrandomized Clinical Trial. JAMA Ophthalmol. 2026 May 1;144(5):442-451. doi: 10.1001/jamaophthalmol.2026.0610. PubMed 41954903 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 13, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06771271
Lead sponsor
Hoffmann-La Roche
Responsible party
Sponsor
First posted
Jan 13, 2025
Start date
Jul 22, 2019
Primary completion
Nov 13, 2023
Completion
Nov 13, 2023
Last update
Jan 13, 2025

Study contacts

Clinical Trials
study director · Hoffmann-La Roche

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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