A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of IVT MHU650 in Macular Edema Patients

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

21 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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 vision by delivering the medicine directly to the affected area.

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.

What safety data exists for the treatment known as MHU650 or MCNU?

MCNU has been studied in children with leukemia or lymphoma, showing no acute toxicity at high doses, but it can cause reversible lung inflammation. In animal studies, MCNU showed less bone marrow toxicity compared to similar drugs, but it still caused some blood-related side effects. ^{1 2 3 4 5}

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. United States pubmed.ncbi.nlm.nih.gov

Propylthiouracil and methimazole display contrasting pathways of peripheral metabolism in both rat and human. [2013]

2. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of high-dose MCNU therapy and hematopoietic stem cell autografts treatment of childhood acute leukemia/lymphoma with high-risk features. [2019]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Suppression of mitogen-induced blastogenesis of feline lymphocytes by in vitro incubation with carcinogenic nitrosamides. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Biologic activity of MCNU: a new antitumor agent. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Methyl-CCNU: preclinical toxicologic evaluation of a single iv infusion in dogs and monkeys. [2013]