A Study to Investigate the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of RO7497372 in Participants With Diabetic Macular Edema (DME)

NCT06847854 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: BP44175
• Study Type: interventional
• Target: 151
• Locations: 2 countries
• Sites: 38

Brief Summary

This study will assess the safety and tolerability of RO7497372 in participants with DME. The study consists of 2 parts. Part 1 will test multiple-ascending doses of RO7497372 after unilateral intravitreal (IVT) administration in participants with DME. The main purpose of Part 1 is to provide data for RO7497372 safety and tolerability, as well as to characterize the ocular and systemic pharmacokinetics (PK), systemic anti-drug antibodies (ADA), and duration of target engagement, i.e., the pharmacodynamics (PD) in aqueous humor (AH) and blood. Part 2 will evaluate the safety, tolerability, PK, and PD of two dose strengths of RO7497372 (low dose and high dose), identified as safe and tolerated in Part 1.

Conditions

Diabetic Macular Edema

Outcome Measures

Primary Outcomes (4)

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

  Up to 28 Weeks

• Part 2: Number of Participants With Intraocular Inflammation (IOI) AEs as Reported by the Investigator

  Baseline to Week 48

• Part 2: Number of Participants With Severe or Serious Drug-Related IOI AEs

  Number of participants with severe or serious drug-related IOI AEs severity will be determined according to the DAIDS toxicity grading scale as reported by the Investigator.

  Baseline to Week 48

• Part 2: Number of Participants With Occlusive Retinal Vasculitis AEs as Reported by the Investigator

  Baseline to Week 48

Secondary Outcomes (15)

• Part 1: Concentration of RO7497372 in Blood

  Up to Week 28

• Part 1: Concentration of RO7497372 in Aqueous Humor (AH)

  Up to Week 28

• Part 2: Number of Participants With AEs

  Up to 56 weeks

• Part 2: Number of Participants With Persistent Treatment-induced Anti-drug Antibody (ADAs)

  Up to 56 weeks

• Part 2: Concentration of RO7497372 in AH

  Up to Week 56

Study Arms (3)

Part 1: Multiple Ascending Dose

EXPERIMENTAL

Participants will receive multiple ascending doses of RO7497372, 3 times every 4 weeks (Q4W) as an IVT injection up to Week 8 in the study eye.

Drug: RO7497372

Part 2: RO7497372 Low Dose

EXPERIMENTAL

Participants will receive 6 doses of RO7497372, low dose, Q4W followed by 3 doses, every eight weeks (Q8W) as an IVT injection up to Week 44 in the study eye.

Drug: RO7497372

Part 2: RO7497372 High Dose

EXPERIMENTAL

Participants will receive 6 doses of RO7497372, high dose, Q4W followed by 3 doses, Q8W as an IVT injection up to Week 44 in the study eye. Treatment in this arm has been discontinued due to the Sponsor's decision.

Drug: RO7497372

Interventions

RO7497372 DRUG

RO7497372 will be administered as IVT injection as per the schedule specified in the arms.

Part 1: Multiple Ascending Dose; Part 2: RO7497372 High Dose; Part 2: RO7497372 Low Dose

Eligibility Criteria

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

You may qualify if:

• Diagnosis of diabetes mellitus (type 1 or type 2), as defined by the world health organization (WHO) and/or American Diabetes Association
• Participant consents to AH collection
• Collection of \> 90 microlitres (µL) AH (at each visit required per schedule of activities \[SoA\]) if deemed feasible and safe by the Investigator.
• Macular thickening secondary to DME involving the center of the fovea with CST \>= 325 µm at screening
• Decreased BCVA primarily due to DME with ETDRS score of 78 to 19 letters (both inclusive) at screening
• Adequately clear ocular media and adequate pupillary dilation to allow acquisition of good quality retinal images
• Diagnosis of non-proliferative DR
• Treatment-naive and Pre-treated participants after washout

You may not qualify if:

• Any major illness or major surgical procedure ≤ 4 weeks before Day 1
• Any febrile illness and associated sequelae ≤ 1 week prior to Day 1
• Active cancer ≤ 1 year prior to Day 1
• Cerebral vascular accident (including stroke and transient ischemic attack) or myocardial infarction ≤ 24 weeks prior to Day 1
• HbA1c ≥ 12% at screening
• Any panretinal photocoagulation or macular laser photocoagulation treatment prior to Day 1
• History of vitreoretinal surgery/pars plana vitrectomy
• Any cataract surgery within 12 weeks prior to Day 1 or any planned surgery during the study
• History of any glaucoma surgery including laser glaucoma procedures
• Uncontrolled glaucoma
• Any active intra- or periocular infection on Day 1
• Any active or history of Intraocular inflammation
• Intravitreal treatment with an anti-IL-6 (e.g., vamikibart) or anti-IL-6 receptor treatment at any time
• Any proliferative DR

Sponsors & Collaborators

• Genentech, Inc.: lead

Study Sites (38)

Barnet Dulaney Perkins Eye Center

Mesa, Arizona, 85206, United States

Location

Retinal Consultants of AZ, Ltd

Peoria, Arizona, 85381, United States

Location

Associated Retina Consultants

Phoenix, Arizona, 85020, United States

Location

Arkansas Retina Research

Little Rock, Arkansas, 72205, United States

Location

Global Research Management

Glendale, California, 91204, United States

Location

Retinal Consultants Medical Group

Modesto, California, 95356, United States

Location

Bay Area Retina Associates

Walnut Creek, California, 94598, United States

Location

Florida Eye Associates

Melbourne, Florida, 32901, United States

Location

Medeye Associates

South Miami, Florida, 33143, United States

Location

East Florida Eye Institute

Stuart, Florida, 34994, United States

Location

Retina Specialists of Tampa

Wesley Chapel, Florida, 33544, United States

Location

Center for Retina and Macula Disease

Winter Haven, Florida, 33880, United States

Location

Cumberland Valley Retina PC

Hagerstown, Maryland, 21740, United States

Location

Retina Associates of Michigan

Grand Blanc, Michigan, 48439-8301, United States

Location

Foundation for Vision Research

Grand Rapids, Michigan, 49546, United States

Location

Retina Consultants Minnesota

Saint Louis Park, Minnesota, 55416, United States

Location

Mississippi Retina Associates

Madison, Mississippi, 39202, United States

Location

The Retina Institute

St Louis, Missouri, 63128, United States

Location

Sierra Eye Associates

Reno, Nevada, 89502, United States

Location

Ross Eye Institute

Buffalo, New York, 14209-2102, United States

Location

Retina Associates of NY

New York, New York, 10075, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44106, United States

Location

Verum Research LLC

Eugene, Oregon, 97401, United States

Location

EyeHealth Northwest

Portland, Oregon, 97225, United States

Location

Erie Retinal Surgery

Erie, Pennsylvania, 16507, United States

Location

Mid Atlantic Retina

Philadelphia, Pennsylvania, 19107, United States

Location

Carolina Eyecare Physicians

Mt. Pleasant, South Carolina, 29464, United States

Location

Charles Retina Institute

Germantown, Tennessee, 38138, United States

Location

Austin Clinical Research LLC

Austin, Texas, 78750, United States

Location

Brown Retina Institute

Schertz, Texas, 78154, United States

Location

Retina Consultants of Texas

The Woodlands, Texas, 77384, United States

Location

Salt Lake Retina

West Jordan, Utah, 84088, United States

Location

Retina Group of Washington

Fairfax, Virginia, 20815, United States

Location

Emerson Clinical Research Institute

Falls Church, Virginia, 78503, United States

Location

Piedmont Eye Center

Lynchburg, Virginia, 24502, United States

Location

Wagner Kapoor Institute

Norfolk, Virginia, 23502, United States

Location

Spokane Eye Clinical Research

Spokane, Washington, 99204-2509, United States

Location

Emanuelli Research and Development Center

Arecibo, 00612, Puerto Rico

Location

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

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

Model Details: Part 1 is Sequential Assignment. Part 2 is Parallel Assignment.

Study Record Dates

• First Submitted: February 21, 2025
• First Posted: February 26, 2025
• Study Start: December 8, 2022
• Primary Completion (Estimated): November 16, 2026
• Study Completion (Estimated): January 12, 2027
• Last Updated: June 4, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (37); PR (1)