MHU650 for Macular Edema

No longer recruiting at 10 trial locations

Overseen By Novartis Pharmaceuticals

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Novartis Pharmaceuticals

Disqualifiers: Proliferative diabetic retinopathy, Vitreous hemorrhage, Retinal detachment, others

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

Compensation: Varies

Number of Visits: 2

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called MHU650 for individuals with macular edema, a condition that causes eye swelling and can lead to vision problems. Researchers aim to determine the safety of MHU650 and how the body processes it. The trial includes different participant groups to test various doses of the treatment. It suits those with vision loss due to macular edema related to conditions like diabetic eye disease or age-related macular issues. As a Phase 1 trial, the research focuses on understanding 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 information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Is there any evidence suggesting that MHU650 is likely to be safe for humans?

Research has shown that MHU650 has been tested in patients with macular edema, yielding promising results. Previous studies found that this treatment is well-tolerated, with no immediate harmful effects, particularly in children with leukemia or lymphoma. This indicates the drug does not cause problems immediately after use.

Since this trial is in an early phase, it primarily focuses on safety and how well people tolerate the drug. Its current testing in humans indicates it passed earlier tests in labs and animals. Although detailed information on side effects is limited, early results suggest patients tolerate MHU650 well.

Consult a doctor before joining a trial to understand any potential risks or benefits. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for macular edema, which often involve repeated injections or laser therapy, MHU650 is designed to be administered as a single dose. This treatment is particularly exciting because it uses an innovative delivery method, potentially reducing the need for frequent doctor visits. Researchers are optimistic about MHU650 because it may offer a more convenient and less invasive option for patients, while still effectively addressing the fluid buildup in the retina that causes vision problems.

What evidence suggests that MHU650 might be an effective treatment for macular edema?

Initial findings suggest that the new treatment, MHU650, might help reduce eye swelling in people with macular edema. Macular edema occurs when fluid builds up in part of the eye, leading to vision problems. MHU650 aims to decrease this swelling to improve vision. So far, research has found no safety concerns, which is promising. While more information is needed, understanding how MHU650 works offers hope for its effectiveness in treating this eye condition. Participants in this trial will join one of the various treatment cohorts to evaluate the effects of MHU650. ^{1 3 5 6 7}

Who Is on the Research Team?

Novartis Pharmaceuticals

Principal Investigator

Novartis Pharmaceuticals

Are You a Good Fit for This Trial?

Inclusion Criteria

Your vital signs are in accordance with the study protocol.

You have satisfactory vision and adequate dilation of the pupils in order to capture sufficiently detailed fundus photographs for measuring retinal artery and vein diameters.

Your ETDRS letter score in the study eye must be between 24 and 60 letters (20/320 to 20/63), while your non-study eye should have a minimum of 60 letters at screening and baseline.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

8 weeks

Treatment

Participants receive a single intravitreal dose of MHU650

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

Multiple visits on Days 1, 2, 5, 15, 29, 43, and 60

Post-study safety follow-up

A safety phone contact call occurs 30 days after the end of study visit

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• MHU650

How Is the Trial Designed?

Group I: Cohort 4 Experimental Treatment 1 Intervention

Cohort 4, open-label, non-randomized, single administration

Group II: Cohort 3 Experimental Treatment 1 Intervention

Cohort 3, open-label; non-randomized, single administration

Group III: Cohort 2 Experimental Treatment 1 Intervention

Cohort 2; open-label, non-randomized, single administration

Group IV: Cohort 1 Experimental Treatment 1 Intervention

Cohort 1; open-label, non-randomized, single administration

Who Is Running the Clinical Trial?

Novartis Pharmaceuticals

Lead Sponsor

Trials

2,963

Recruited

4,275,000+

Founded

1996

Headquarters

Basel, Switzerland

Known For

Precision medicine

Top Products

Gleevec, Cosentyx, Entresto, Kisqali

Dr. Vas Narasimhan

Novartis Pharmaceuticals

Chief Executive Officer since 2018

MD from Harvard Medical School

Dr. Shreeram Aradhye

Novartis Pharmaceuticals

Chief Medical Officer since 2021

MD

Citations

1. withpower.com withpower.com/trial/phase-1-retinal-vein-occlusion-10-2020-66485

A Study to Evaluate the Safety, Tolerability and ... This trial tests a new eye injection treatment called MHU650 for people with macular edema. The goal is to see if it can reduce eye swelling and improve ...

2. retinatoday.com retinatoday.com/articles/2022-nov-dec/whats-in-the-works-for-wet-amd

What's in the Works for Wet AMD MHU650 (Novartis), administered as a single intravitreal injection, completed a phase 1 single ascending dose study with results pending (NCT04635800). HMR59 ( ...

3. novctrd.com novctrd.com/ctrdweb/patientsummary/patientsummaries?patientSummaryId=1501

The safety of MHU650 for people with macular edema ... The researchers concluded that there were no safety concerns for MHU650 in this trial. Additional results are also provided later in this summary. Page 3 ...

4. aging.networkofcare.org aging.networkofcare.org/sanmateo/CommunityResources/ClinicalTrials/Detail/NCT04635800?keyword=%22DME%22

San Mateo Clinical Trial A Study to Evaluate the Safety ... A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of IVT MHU650 in Macular Edema Patients ... MHU650 in up to 24 participants with macular edema.

5. novctrd.com novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=18049

Sponsor Generic Drug Name Trial Indication(s) Protocol ... Primary: To evaluate the safety and tolerability of a single IVT dose of MHU650 in participants with macular edema. Secondary: To evaluate the serum ...

6. ctv.veeva.com ctv.veeva.com/study/a-study-to-evaluate-the-safety-tolerability-and-pharmacokinetics-of-ivt-mhu650-in-macular-edema-pat

A Study to Evaluate the Safety, Tolerability and ... A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of IVT MHU650 in Macular Edema Patients · Timeline · Sponsor of this trial.

7. synapse.patsnap.com synapse.patsnap.com/drug/f49196a3615b418196f7904c9daa2402

MHU-650 - Drug Targets, Indications, Patents A First-in-human, Open-label, Single Ascending Dose Study to Assess Safety and Tolerability of Intravitreal MHU650 in Participants With Macular Edema From ...