RO7497372 for Diabetic Macular Edema

(Pregonda Trial)

Recruiting in Palo Alto (17 mi)

+11 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Genentech, Inc.

Must not be taking: Anti-IL-6 treatments

Disqualifiers: Active cancer, Stroke, Myocardial infarction, Uncontrolled glaucoma, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it mentions a 'washout' period for pre-treated participants, which means you might need to stop certain treatments before starting the trial.

What data supports the effectiveness of the drug RO7497372 for Diabetic Macular Edema?

Research shows that anti-VEGF therapies, which are similar to RO7497372, have been effective in improving vision in patients with diabetic macular edema by reducing swelling in the eye. ^{1 2 3 4 5}

Research Team

Clinical Trials

Principal Investigator

Hoffmann-La Roche

Eligibility Criteria

This trial is for individuals with Diabetic Macular Edema (DME), a condition where fluid accumulates in the retina due to diabetes. Participants should have DME in one eye and be willing to receive injections directly into the eye. Specific eligibility details are not provided, but typically include age range, disease severity, and no recent treatments that could interfere.

Inclusion Criteria

Participant consents to AH collection

I have not started treatment or have completed a treatment washout period.

I have been diagnosed with diabetes (type 1 or type 2).

Exclusion Criteria

I have not had a fever or its effects in the last week.

I haven't had cataract surgery in the last 12 weeks and don't plan any surgery during the study.

I haven't had a major illness or surgery in the last 4 weeks.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part 1

Participants receive multiple ascending doses of RO7497372, 3 times every 4 weeks as an IVT injection up to Week 8

8 weeks

Treatment Part 2

Participants receive 6 doses of RO7497372, either low or high dose, every 4 weeks followed by 3 doses every 8 weeks as an IVT injection up to Week 44

44 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Treatment Details

Interventions

• RO7497372 (Monoclonal Antibodies)

Trial Overview The study tests RO7497372, a new medication given as an injection inside the eye (intravitreal) for treating DME. It has two parts: Part 1 determines safety and how the body processes it; Part 2 tests two different doses found safe in Part 1 for their effectiveness and side effects.

Participant Groups

Group I: Part 2: RO7497372 Low Dose Experimental Treatment 1 Intervention

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.

Group II: Part 2: RO7497372 High Dose Experimental Treatment 1 Intervention

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.

Group III: Part 1: Multiple Ascending Dose Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Genentech, Inc.

Lead Sponsor

Trials

1,578

Recruited

569,000+

Ashley Magargee

Genentech, Inc.

Chief Executive Officer since 2024

MBA from Harvard University, BA from Princeton University

Levi Garraway

Genentech, Inc.

Chief Medical Officer since 2021

MD, PhD

References

1. England pubmed.ncbi.nlm.nih.gov

An open-source data set of anti-VEGF therapy in diabetic macular oedema patients over 4 years and their visual acuity outcomes. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Visual acuity outcomes and anti-VEGF therapy intensity in diabetic macular oedema: a real-world analysis of 28 658 patient eyes. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Translating evidence into practice: recommendations by a UK expert panel on the use of aflibercept in diabetic macular oedema. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Treat-and-extend regimens of anti-vascular endothelial growth factor therapy for retinal vein occlusions: a systematic review and meta-analysis. [2022]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Combination Therapy for Macular Oedema in Retinal Vein Occlusions: 3-Year Results from a Real-World Clinical Practice. [2022]