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Diabetic Macular EdemaPhase 1DOVETAILNCT06771271

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

A Phase 1 study testing RO7200220 and Ranibizumab in people with Diabetic Macular Edema and Uveitic Macular Edema, run by Hoffmann-La Roche at 19 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetic Macular Edema, Uveitic Macular Edema
What is being tested?
RO7200220 and Ranibizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
85 participants
Where
19 sitesUnited States
Study dates
22 Jul 2019to 13 Nov 2023
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
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  • 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).

Who cannot join

  • 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
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  • 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

Trial locations and contacts

19 sites in 1 country.

19 sites in 1 country

United States19 sites

  • Retina Res Institute of Texas

    Abilene, Texas, 79606

  • Austin Clinical Research LLC

    Austin, Texas, 78750

  • Retina-Vitreous Associates Medical Group

    Beverly Hills, California, 90211

  • Univ of Virginia Ophthalmology

    Charlottesville, Virginia, 22903

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Cumberland Valley Retina PC

    Hagerstown, Maryland, 21740

  • Valley Retina Institute P.A.

    McAllen, Texas, 78503

  • Florida Eye Associates

    Melbourne, Florida, 32901

  • Illinois Retina Associates SC

    Oak Park, Illinois, 60304

  • California Retina Consultants

    Oxnard, California, 93036

  • Retina Institute of California Medical Group d/b/a Acuity Eye Group

    Palm Desert, California, 92260

  • Byers Eye Insitute at Stanford

    Palo Alto, California, 94303

  • Mid Atlantic Retina

    Philadelphia, Pennsylvania, 19107

  • Oregon HSU

    Portland, Oregon, 97239

  • Sierra Eye Associates

    Reno, Nevada, 89502

  • Medical Center Ophthalmology Associates

    San Antonio, Texas, 78240

  • Karalis Johnson Retina Center

    Seattle, Washington, 98109

  • Retina Vitreous Assoc of FL

    St. Petersburg, Florida, 33711

  • Wake Forest Baptist Medical Center

    Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

Official title: 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).

Being tested
RO7200220, Ranibizumab

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RO7200220Drug

    Also called Vamikibart

    RO7200220 was administered as IVT injection.

  • RanibizumabDrug

    Ranibizumab was administered as IVT injection.

Study groups in NCT06771271
Study groupRoleWhat they receive
Part 1: RO7200220 MonotherapyExperimentalParticipants 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.
Receives: Drug: RO7200220
Part 2: Expansion of RO7200220 MonotherapyExperimentalParticipants 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.
Receives: Drug: RO7200220
Part 3: RO7200220 in Combination with RanibizumabExperimentalParticipants with DME received RO7200220 as IVT injection followed by ranibizumab, 0.5 milligrams (mg) as IVT injection in Part 3.
Receives: Drug: RO7200220; Drug: Ranibizumab
Part 4: RO7200220 MonotherapyExperimentalParticipants with UME received multiple doses of RO7200220 (three doses at the assigned dose level), as IVT injection, Q4W in multiple cohorts.
Receives: Drug: RO7200220

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Up to 18 weeks

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

    Measured: Up to 24 weeks

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

    Measured: Up to 20 weeks

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

    Measured: Up to 36 weeks

Secondary outcomes (4)

  1. Maximum Serum Concentration (Cmax)

    Measured: 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)

    Measured: 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)

    Measured: 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)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jan 2025
  2. Study start22 Jul 2019
  3. Primary completion13 Nov 2023
  4. Study completion13 Nov 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
85 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06771271
Sponsor's protocol ID
BP40899
Acronym
DOVETAIL
Status last verified
Jan 2025
First submitted
8 Jan 2025
Last updated
13 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing RO7200220 and Ranibizumab in people with Diabetic Macular Edema and Uveitic Macular Edema, run by Hoffmann-La Roche at 19 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1: Number of Participants With Adverse Events (AEs) (time frame: Up to 18 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06771271, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2025.

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