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Diabetic Macular EdemaPhase 1PregondaNCT06847854

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 testing RO7497372 in people with Diabetic Macular Edema, run by Genentech, Inc. at 38 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetic Macular Edema
What is being tested?
RO7497372
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
151 participants
Where
38 sitesin 2 countries
Study dates
8 Dec 2022to 18 Jan 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

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

  • 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

Who cannot join

  • 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
Show all 14Show fewer
  • 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

Trial locations and contacts

38 sites in 2 countries.

38 sites in 2 countries

United States37 sites

  • Austin Clinical Research LLC

    Austin, Texas, 78750

  • Ross Eye Institute

    Buffalo, New York, 14209

  • Cleveland Clinic

    Cleveland, Ohio, 44106

  • Erie Retinal Surgery

    Erie, Pennsylvania, 16507

  • Verum Research LLC

    Eugene, Oregon, 97401

  • Retina Group of Washington

    Fairfax, Virginia, 20815

  • Emerson Clinical Research Institute

    Falls Church, Virginia, 78503

  • Charles Retina Institute

    Germantown, Tennessee, 38138

  • Global Research Management

    Glendale, California, 91204

  • Retina Associates of Michigan

    Grand Blanc, Michigan, 48439

  • Foundation for Vision Research

    Grand Rapids, Michigan, 49546

  • Cumberland Valley Retina PC

    Hagerstown, Maryland, 21740

  • Arkansas Retina Research

    Little Rock, Arkansas, 72205

  • Piedmont Eye Center

    Lynchburg, Virginia, 24502

  • Mississippi Retina Associates

    Madison, Mississippi, 39202

  • Florida Eye Associates

    Melbourne, Florida, 32901

  • Barnet Dulaney Perkins Eye Center

    Mesa, Arizona, 85206

  • Retinal Consultants Medical Group

    Modesto, California, 95356

  • Carolina Eyecare Physicians

    Mt. Pleasant, South Carolina, 29464

  • Retina Associates of NY

    New York, New York, 10075

  • Wagner Kapoor Institute

    Norfolk, Virginia, 23502

  • Retinal Consultants of AZ, Ltd

    Peoria, Arizona, 85381

  • Mid Atlantic Retina

    Philadelphia, Pennsylvania, 19107

  • Associated Retina Consultants

    Phoenix, Arizona, 85020

  • EyeHealth Northwest

    Portland, Oregon, 97225

  • Sierra Eye Associates

    Reno, Nevada, 89502

  • Retina Consultants Minnesota

    Saint Louis Park, Minnesota, 55416

  • Brown Retina Institute

    Schertz, Texas, 78154

  • Medeye Associates

    South Miami, Florida, 33143

  • Spokane Eye Clinic

    Spokane, Washington, 99204

  • The Retina Institute

    St Louis, Missouri, 63128

  • East Florida Eye Institute

    Stuart, Florida, 34994

  • Retina Consultants of Texas

    The Woodlands, Texas, 77384

  • Bay Area Retina Associates

    Walnut Creek, California, 94598

  • Retina Specialists of Tampa

    Wesley Chapel, Florida, 33544

  • Salt Lake Retina

    West Jordan, Utah, 84088

  • Center for Retina and Macula Disease

    Winter Haven, Florida, 33880

Other trials in United States

Puerto Rico1 site

  • Emanuelli Research and Development Center LLC

    Arecibo, 00612

Other trials in Puerto Rico

About this study

Official title: A Phase I, Multipart, Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO7497372 Following Intravitreal Administration in Participants With Diabetic Macular Edema (Part 1 Non-Randomized, Open-Label, Multiple Ascending Dose; Part 2 Randomized, Double-Masked)

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.

Being tested
RO7497372

What participants receive

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

  • RO7497372Drug

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

Study groups in NCT06847854
Study groupRoleWhat they receive
Part 1: Multiple Ascending DoseExperimentalParticipants 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.
Receives: Drug: RO7497372
Part 2: RO7497372 Low DoseExperimentalParticipants 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.
Receives: Drug: RO7497372
Part 2: RO7497372 High DoseExperimentalParticipants 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.
Receives: Drug: RO7497372

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 28 Weeks

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

    Measured: Baseline to Week 48

  3. 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.

    Measured: Baseline to Week 48

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

    Measured: Baseline to Week 48

Secondary outcomes (15)

  1. Part 1: Concentration of RO7497372 in Blood

    Measured: Up to Week 28

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

    Measured: Up to Week 28

  3. Part 2: Number of Participants With AEs

    Number of participants with AEs severity determined according to the DAIDS toxicity grading scale.

    Measured: Up to 56 weeks

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

    Measured: Up to 56 weeks

  5. Part 2: Concentration of RO7497372 in AH

    Measured: Up to Week 56

  6. Part 2: Concentration of RO7497372 in Plasma

    Measured: Up to Week 56

  7. Part 2: Change From Baseline in Best Corrected Visual Acuity (BCVA) Score Over Time

    BCVA will be measured via Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters using a set of three Precision VisionTM or lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R) prior to dilating eyes by a trained and certified visual acuity (VA) examiner. The range of EDTRS is 0 to 100 letters. Higher scores indicates improvement in VA.

    Measured: From Baseline (Day 1) up to Week 56

  8. Part 2: Absolute Value of BCVA Score Over Time

    BCVA will be measured via ETDRS chart at a starting distance of 4 meters using a set of three Precision VisionTM or lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R) prior to dilating eyes by a trained and certified VA examiner. The range of EDTRS is 0 to 100 letters. Higher scores indicates improvement in VA.

    Measured: Up to Week 56

  9. Part 2: Percentage of Participants Gaining ≥ 15, ≥ 10, ≥ 5, or ≥ 0 Letters in BCVA From Baseline Over Time

    BCVA will be measured via ETDRS chart at a starting distance of 4 meters using a set of three Precision VisionTM or lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R) prior to dilating eyes by a trained and certified VA examiner. The range of EDTRS is 0 to 100 letters. Higher scores indicates improvement in VA.

    Measured: Up to Week 56

  10. Part 2: Percentage of Participants Avoiding a Loss of ≥ 15, ≥ 10, ≥ 5, or ≥ 0 Letters in BCVA From Baseline Over Time

    BCVA will be measured via ETDRS chart at a starting distance of 4 meters using a set of three Precision VisionTM or lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R) prior to dilating eyes by a trained and certified VA examiner. The range of EDTRS is 0 to 100 letters. Higher scores indicates improvement in VA.

    Measured: Up to Week 56

  11. Part 2: Change From Baseline in Central Subfield Thickness (CST) Over Time

    CST is defined as the average thickness of the central 1-mm circle of the ETDRS grid centered to the fovea measured between the internal limiting membrane and the Bruch's membrane. CST will be determined by CRC evaluation of SD-OCT images.

    Measured: From Baseline (Day 1) up to Week 56

  12. Part 2: Absolute Value of CST Over Time

    CST is defined as the average thickness of the central 1-mm circle of the ETDRS grid centered to the fovea measured between the internal limiting membrane and the Bruch's membrane. CST will be determined by CRC evaluation of SD-OCT images.

    Measured: Up to Week 56

  13. Part 2: Percentage of Participants With Absence of DME Over Time

    Absence of DME is defined as CST < 325 micrometre (μm) by spectral domain optical coherence tomography (SD-OCT).

    Measured: Up to Week 56

  14. Part 2: Percentage of Participants With Absence of Intraretinal Fluid and/or Subretinal Fluid Over Time

    Presence of intraretinal and subretinal fluid will be determined by CRC evaluation of SD -OCT images.

    Measured: Up to Week 56

  15. Part 2: Percentage of Participants With ≥ 2-step Diabetic Retinopathy Severity Scale (DRSS) Improvement From Baseline on the ETDRS DRSS Over Time

    The DRSS will be graded according to ETDRS grading schedules from report 18 JOVS, February 1998, Vol. 39, No. 2. ETDRS DRSS is 13 step scale which measures severity of diabetic retinopathy (DR). The DRSS scores vary from 10 (DR absent) to 90 (ungradable proliferative diabetic retinopathy(PDR)). Higher levels indicate higher severity.

    Measured: Up to Week 56

Timeline

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

  1. First posted26 Feb 2025
  2. Study start8 Dec 2022
  3. Primary completion16 Nov 2026 (estimated)
  4. Study completion18 Jan 2027 (estimated)

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
Randomised
Intervention model
Sequential
Model description
Part 1 is Sequential Assignment. Part 2 is Parallel Assignment.
Masking
None (open label)
Enrolment
151 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06847854
Sponsor's protocol ID
BP44175
Acronym
Pregonda
Status last verified
Sep 2026
First submitted
21 Feb 2025
Last updated
2 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing RO7497372 in people with Diabetic Macular Edema, run by Genentech, Inc. at 38 sites in 2 countries.

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 8 inclusion and 14 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: under way, not looking for participants, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 38 sites in United States, Puerto Rico. 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?

This study is still under way. Results are not available in the source record yet.

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 28 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 NCT06847854.

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 2 Sep 2026.

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