RO7497372 for Diabetic Macular Edema

(Pregonda Trial)

Recruiting at 33 trial locations

Overseen By Reference Study ID Number: BP44175 https://forpatients.roche.com/

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Genentech, Inc.

Must not be taking: Anti-IL-6 treatments

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

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

176 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the safety and tolerability of a new treatment, RO7497372, for individuals with diabetic macular edema (DME), a condition that causes vision problems due to fluid build-up in the eye. The trial consists of two parts: initially, it tests different doses to determine a safe range, and then it further examines two specific doses. It is suitable for individuals with diabetes experiencing vision issues due to DME, particularly if their condition affects the center of their vision and they have not recently undergone certain eye surgeries or treatments. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

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.

Is there any evidence suggesting that RO7497372 is likely to be safe for humans?

Research shows that RO7497372 is undergoing testing to determine its safety and tolerability in people with diabetic macular edema (DME). In this early stage, the main goal is to observe responses to the treatment and identify any side effects. As one of the first human trials, limited information exists about its safety. However, early trials like this closely monitor the body's reactions, including any negative effects. Researchers carefully monitor participants to ensure their safety as they receive different doses of the treatment. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for diabetic macular edema?

Researchers are excited about RO7497372 for diabetic macular edema because it may offer a new mechanism of action compared to standard treatments like anti-VEGF injections. Unlike typical therapies that primarily inhibit vascular endothelial growth factor, RO7497372 targets a different pathway, which could provide benefits to patients who do not respond well to existing options. Additionally, the flexible dosing schedule of RO7497372, transitioning from more frequent to less frequent injections, might improve patient convenience and adherence. These factors make RO7497372 a promising candidate in the quest for more effective treatments for diabetic macular edema.

What evidence suggests that RO7497372 might be an effective treatment for diabetic macular edema?

Research has shown that RO7497372 may improve vision for people with macular edema. In an earlier study involving patients with blocked veins in their retinas, this treatment improved vision by an average of about 16 letters on an eye chart after a year. This finding suggests that RO7497372 might also benefit people with diabetic macular edema (DME). In this trial, participants will receive either high or low doses of RO7497372 to evaluate its effectiveness in treating DME. The treatment targets the causes of swelling in the eye. Although more research is needed, early results are promising for its use in treating DME. ^{1 2 3 6 7}

Who Is on the Research Team?

Clinical Trials

Principal Investigator

Hoffmann-La Roche

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• RO7497372

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

Aflibercept should be initiated with intensive proactive dosing of 2 mg every 4 weeks, with most experts recommending six initial doses based on clinical experience, which aligns with Protocol T rather than the five doses suggested in the product guidelines.

For patients showing a good response but not yet stable, continuing with 4-weekly aflibercept is advised until stability is achieved, while those with no response may need to consider switching to other treatments, highlighting the importance of tailored approaches in managing diabetic macular oedema.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Translating evidence into practice: recommendations by a UK expert panel on the use of aflibercept in diabetic macular oedema. Pearce, I., Bailey, C., Fletcher, E., et al.[2021]

In a study of 66 patients with macular oedema due to retinal vein occlusions, combination therapy (initial Ranibizumab with optional Ozurdex and laser) led to significant improvements in visual acuity over three years, with 63% of patients experiencing better vision.

The treatment also resulted in a notable reduction in the frequency of injections needed, with 39.6% of patients not requiring any injections by Year 3, indicating a long-term efficacy and safety of the combination therapy in managing this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combination Therapy for Macular Oedema in Retinal Vein Occlusions: 3-Year Results from a Real-World Clinical Practice. Horner, F., Lip, PL., Mushtaq, B., et al.[2022]

In a study of 2614 eyes from 1964 patients with diabetic macular oedema, intravitreal anti-VEGF injections led to significant visual acuity improvements, with half of the patients achieving a favorable outcome of more than 70 letters on the Early Treatment Diabetic Retinopathy Study scale within 1.9 months.

However, among those who initially reached this visual acuity, 50% experienced a decline below 70 letters by 14.7 months, indicating that while anti-VEGF therapy is effective, its benefits may diminish over time.

NCBI (Pubmed)

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. Kern, C., Fu, DJ., Huemer, J., et al.[2022]

In a study of 28,658 treatment-naïve patients with diabetic macular edema (DMO), those who received an average of 6.4 anti-VEGF injections over one year gained a mean of +4.2 letters in visual acuity, indicating a positive but modest improvement.

Patients with moderately severe baseline visual impairment (20/70 to 20/200) who received 10 or more injections showed significant improvement (+10.3 letters), while those with better baseline vision (≥20/40) were at risk of losing visual acuity, highlighting the importance of treatment intensity and baseline condition in visual outcomes.

NCBI (Pubmed)

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. Ciulla, TA., Pollack, JS., Williams, DF.[2021]

The treat-and-extend (T&E) regimen of anti-VEGF therapy for macular edema due to retinal vein occlusions showed a significant mean improvement of 15.7 ETDRS letters after 12 months, indicating effective treatment outcomes.

Central retinal thickness also improved by an average of 269.7 μm at 12 months, with relatively few adverse events reported, suggesting that T&E regimens are both effective and safe for this condition.

NCBI (Pubmed)

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. Nanji, K., Khan, M., Khalid, MF., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06847854

NCT06847854 | A Study to Investigate the Safety, ... 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 ...

2. withpower.com withpower.com/trial/phase-1-macular-edema-11-2022-ab596

RO7497372 for Diabetic Macular Edema (Pregonda Trial) ... macular edema due to retinal vein occlusions showed a significant mean improvement of 15.7 ETDRS letters after 12 months, indicating effective treatment ...

3. research.buffalo.edu research.buffalo.edu/portal/clinicaltrial/protocol/23560

Clinical Trial for People with Diabetic Macular Edema The goal of the study is to see the effects (either good or bad) of a new drug (called RO7497372) to treat DME.

4. go.drugbank.com go.drugbank.com/conditions/DBCOND0060562

Diabetic Macular Edema (DME) (DBCOND0060562) ... RO7497372 in Participants With Diabetic Macular Edema (DME) ... Efficacy and Safety Single-Arm Descriptive Trial in Patients With Persistent Diabetic Macular Edema.

5. forpatients.roche.com forpatients.roche.com/content/patient-platform/global/en/trials/eye-disorder/dme/a-study-to-investigate-the-safety--tolerability--pharma-00389.pdf

A Study to Investigate the Safety, Tolerability ... - ForPatients 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 ...

6. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/578996

A Study to Investigate the Safety, Tolerability ... This study will assess the safety and tolerability of RO7497372 in participants with DME. The study consists of 2 parts.

7. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/578996

A Study to Investigate the Safety, Tolerability ... 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 ...