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

NCT06771271 | Completed Phase 1 FDA Drug

• 1 other identifier: BP40899
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 19

Brief 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).

Conditions

Diabetic Macular Edema; Uveitic Macular Edema

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• 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

Study Arms (4)

Part 1: RO7200220 Monotherapy

EXPERIMENTAL

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

Part 2: Expansion of RO7200220 Monotherapy

EXPERIMENTAL

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

Part 3: RO7200220 in Combination with Ranibizumab

EXPERIMENTAL

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

Part 4: RO7200220 Monotherapy

EXPERIMENTAL

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

RO7200220 DRUG

RO7200220 was administered as IVT injection.

Also known as: Vamikibart

Part 1: RO7200220 Monotherapy; Part 2: Expansion of RO7200220 Monotherapy; Part 3: RO7200220 in Combination with Ranibizumab; Part 4: RO7200220 Monotherapy

Ranibizumab DRUG

Ranibizumab was administered as IVT injection.

Part 3: RO7200220 in Combination with Ranibizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (19)

Retina-Vitreous Associates Medical Group

Beverly Hills, California, 90211, United States

Location

California Retina Consultants

Oxnard, California, 93036, United States

Location

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

Palm Desert, California, 92260, United States

Location

Byers Eye Insitute at Stanford

Palo Alto, California, 94303, United States

Location

Florida Eye Associates

Melbourne, Florida, 32901, United States

Location

Retina Vitreous Assoc of FL

St. Petersburg, Florida, 33711, United States

Location

Illinois Retina Associates SC

Oak Park, Illinois, 60304, United States

Location

Cumberland Valley Retina PC

Hagerstown, Maryland, 21740, United States

Location

Sierra Eye Associates

Reno, Nevada, 89502, United States

Location

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Oregon HSU

Portland, Oregon, 97239, United States

Location

Mid Atlantic Retina

Philadelphia, Pennsylvania, 19107, United States

Location

Retina Res Institute of Texas

Abilene, Texas, 79606, United States

Location

Austin Clinical Research LLC

Austin, Texas, 78750, United States

Location

Valley Retina Institute P.A.

McAllen, Texas, 78503, United States

Location

Medical Center Ophthalmology Associates

San Antonio, Texas, 78240, United States

Location

Univ of Virginia Ophthalmology

Charlottesville, Virginia, 22903, United States

Location

Karalis Johnson Retina Center

Seattle, Washington, 98109, United States

Location

MeSH Terms

Interventions

Ranibizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2025
• First Posted: January 13, 2025
• Study Start: July 22, 2019
• Primary Completion: November 13, 2023
• Study Completion: November 13, 2023
• Last Updated: January 13, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (19)