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NCT06847854 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Diabetic Macular Edema, sponsored by Genentech.

Active
Registry status
Phase 1
Development phase
151
Enrollment target
20
Study locations

NCT06847854 is a Phase 1 study of Diabetic Macular Edema that is active but no longer recruiting, run by Genentech. The registered enrollment target is 151 participants, below the 3,792-participant average among 63 other Diabetic Macular Edema trials with a reported enrollment target (96% lower). The trial reports 20 study locations across 11 states.

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The verdict

NCT06847854, a Phase 1 study of Diabetic Macular Edema, is active but no longer recruiting, sponsored by Genentech.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
151 participants
Enrollment target
20
Study locations

Study 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 Studied

Diabetic Macular Edema

Interventions

  • DRUG RO7497372

Study Locations (20)

Florida

  • Florida Eye Associates - Melbourne
  • Medeye Associates - Miami
  • East Florida Eye Institute - Stuart
  • Retina Specialists of Tampa - Wesley Chapel
  • Center for Retina and Macula Disease - Winter Haven

Arizona

  • Barnet Dulaney Perkins Eye Center - Mesa
  • Retinal Consultants of AZ, Ltd - Peoria
  • Associated Retina Consultants - Phoenix

California

  • Global Research Management - Glendale
  • Retinal Consultants Medical Group - Modesto
  • Bay Area Retina Associates - Walnut Creek

Michigan

  • Retina Associates of Michigan - Grand Blanc
  • Foundation for Vision Research - Grand Rapids

Arkansas

  • Arkansas Retina Research - Little Rock

Maryland

  • Cumberland Valley Retina PC - Hagerstown

Minnesota

  • Retina Consultants Minnesota - Saint Louis Park

Mississippi

  • Mississippi Retina Associates - Madison

Trial Details

FieldValue
Enrollment Target 151 participants
Start Date 2022-12-08
Est. Completion 2027-04-30
Phase Phase 1

Sponsor

Genentech

332 total trials

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What the Registry Record Tells You About NCT06847854

The ClinicalTrials.gov registry entry for NCT06847854 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 151 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,792-participant average among 63 other Diabetic Macular Edema trials with a reported enrollment target (96% lower). The listed sponsor is Genentech, which has 332 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Diabetic Macular Edema appearing as the primary indexed condition, and to 1 intervention - of which RO7497372 is the first listed.

NCT06847854 reports 20 study locations spanning 11 distinct geographic areas - top geographies include Florida, Arizona, California.

Frequently Asked Questions

What is clinical trial NCT06847854 about?

NCT06847854 is a clinical study titled "A Study to Investigate the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of RO7497372 in Participants With Diabetic Macular Edema (DME)". 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 f...

What is the current status of trial NCT06847854?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 151 participants. The study started on 2022-12-08. Estimated completion is 2027-04-30.

What conditions does trial NCT06847854 study?

This clinical trial studies the following conditions: Diabetic Macular Edema.

What interventions are being tested in trial NCT06847854?

The interventions under investigation include: RO7497372 (DRUG).

Who is sponsoring clinical trial NCT06847854?

This trial is sponsored by Genentech, which has 332 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06847854 being conducted?

This trial has 20 study locations across Arizona, Arkansas, California, Florida, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.