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MHU650 for Retinal Vein Occlusion

Phase 1
Waitlist Available
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up days 1, 2, 5, 15, 29, 43 and 60
Awards & highlights

Summary

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.

Eligible Conditions
  • Retinal Vein Occlusion
  • Diabetic Macular Edema
  • Age-Related Macular Degeneration
  • Macular Edema

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days 1, 2, 5, 15, 29, 43 and 60
This trial's timeline: 3 weeks for screening, Varies for treatment, and days 1, 2, 5, 15, 29, 43 and 60 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline in Best Correct Visual Acuity (BCVA ) by dose level and timepoint - Study Eye
Change from baseline in Central subfield thickness (CSFT) (µm) in the study eye by dose level and timepoint
Change from baseline in Intraocular pressure (IOP) (mmHg) in the study eye by dose level and timepoint
+1 more
Secondary outcome measures
Pharmacokinetics of single dose of MHU650 - AUCinf
Pharmacokinetics of single dose of MHU650 - AUClast
Pharmacokinetics of single dose of MHU650 - Cmax
+2 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: Cohort 4Experimental Treatment1 Intervention
Cohort 4, open-label, non-randomized, single administration
Group II: Cohort 3Experimental Treatment1 Intervention
Cohort 3, open-label; non-randomized, single administration
Group III: Cohort 2Experimental Treatment1 Intervention
Cohort 2; open-label, non-randomized, single administration
Group IV: Cohort 1Experimental Treatment1 Intervention
Cohort 1; open-label, non-randomized, single administration
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MHU650
2020
Completed Phase 1
~30

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Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,874 Previous Clinical Trials
4,199,970 Total Patients Enrolled
14 Trials studying Retinal Vein Occlusion
33,597 Patients Enrolled for Retinal Vein Occlusion
~4 spots leftby Sep 2025
Unbiased ResultsWe believe in providing patients with all the options.
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Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
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