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Completed

NCT Number: NCT04635800

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

This was an open-label, multi-center, FIH study with a single ascending dose (SAD) design that assessed the safety, tolerability and pharmacokinetics (PK) of a single IVT dose of MHU650 in up to 24 participants with macular edema.

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Key information

Conditions

Macular Edema Cardiovascular Diseases Diabetic Macular Edema Embolism and Thrombosis Eye Diseases Geographic Atrophy Macular Degeneration Neovascular Age-related Macular Degeneration Retinal Degeneration Retinal Diseases Retinal Vein Occlusion Thrombosis Vascular Diseases Venous Thrombosis Wet Macular Degeneration

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novartis Investigative Site, Arecibo, Puerto Rico

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About this study

A total of up to 4 cohorts were planned to be enrolled, with an additional lower or intermediate cohort of participants. First to third generation Japanese participants could be enrolled in all cohorts but were not required to be enrolled. The screening period for this study will be up to 60 days. A single dose of MHU650 intravitreal injection will be administered at Baseline / Day 1 in the study eye. The follow up period will last until Day 60 / end of study (EOS). A post study safety phone contact call will occur 30 days after the EOS visit.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • Patients with macular edema in at least one eye, including those with focal or diffuse diabetic macular edema (DME), neovascular age-related macular degeneration (nAMD), or retinal vein occlusion (RVO). In the opinion of the investigator, the decrease in vision in the study eye must be due to macular edema.
  • Early Treatment Diabetic Retinopathy (ETDRS) letter score in the study eye must equal to or worse than 60 letters (approximately Snellen equivalent of 20/63) but better than 14 letters (20/500) at screening and baseline. The ETDRS score in the non-study eye should be ≥ 60 letters at screening and baseline.
  • Sufficiently clear ocular media and adequate pupil dilation to permit fundus photographs of adequate clarity to measure diameters of retinal arteries and veins
  • Vital signs as specified in the protocol

Key Exclusion Criteria:

  • Concomitant conditions or ocular disorders in the study eye which may, in the opinion of the investigator, confound the interpretation of study results, compromise visual acuity or require medical or surgical intervention during the study period
  • High risk and/or/ active proliferative diabetic retinopathy in the study eye, as per investigator assessment at both screening and baseline.
  • Participants with the following conditions in the study eye at screening or baseline must be excluded: structural damage of the fovea, vitreous hemorrhage, retinal detachment, vitreomacular traction, macular hole, retinal arterial occlusion, neovascularization of iris of any cause.
  • Laser photocoagulation (macular or panretinal) in the study eye during the 6-month period prior to baseline.
  • Patients with type 1or type 2 diabetes who have hemoglobin A1C of ≥ 12 at screening
  • Other ocular conditions as specified in the protocol
  • Systemic conditions as specified in the protocol

Treatment and study plan

MHU650

Drug

MHU650 powder for solution for injection

Primary outcomes

  1. Number of participants with ocular and nonocular adverse events

    Time frame: Day 1 to Day 60

    An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign [including abnormal laboratory findings], symptom or disease) in a clinical investigation participant after providing written informed consent for participation in the study.

  2. Change from baseline in Best Correct Visual Acuity (BCVA ) by dose level and timepoint - Study Eye

    Time frame: Day 1 to Day 60

    Best Correct Visual Acuity was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts.

  3. Change from baseline in Central subfield thickness (CSFT) (µm) in the study eye by dose level and timepoint

    Time frame: Day 1 to Day 60

    Central subfield thickness was measured by spectral domain optical coherence tomography (SD-OCT).

  4. Change from baseline in Intraocular pressure (IOP) (mmHg) in the study eye by dose level and timepoint

    Time frame: Day 1 to Day 60

    Intraocular pressure was measured per the sites' local standard operating procedures, via tonometry.

Secondary outcomes

  1. Pharmacokinetics of single dose of MHU650 - Cmax

    Time frame: Days 1, 2, 5, 15, 29, 43 and 60

    Assess serum PK profile of MHU650 by Cmax (if feasibile)

  2. Pharmacokinetics of single dose of MHU650 - Tmax

    Time frame: Days 1, 2, 5, 15, 29, 43 and 60

    Assess serum PK profile of MHU650 by Tmax (if feasibile)

  3. Pharmacokinetics of single dose of MHU650 - T1/2

    Time frame: Days 1, 2, 5, 15, 29, 43 and 60

    Assess serum PK profile of MHU650 by T1/2 (if feasibile)

  4. Pharmacokinetics of single dose of MHU650 - AUClast

    Time frame: Days 1, 2, 5, 15, 29, 43 and 60

    Assess serum PK profile of MHU650 by AUClast (if feasibile)

  5. Pharmacokinetics of single dose of MHU650 - AUCinf

    Time frame: Days 1, 2, 5, 15, 29, 43 and 60

    Assess serum PK profile of MHU650 by AUCinf (if feasibile)

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

A First-in-human, Open-label, Single Ascending Dose Study to Assess Safety and Tolerability of Intravitreal MHU650 in Participants With Macular Edema From Diabetic Macular Edema (DME), Neovascular Age-related Macular Degeneration (nAMD), or Retinal Vein Occlusion (RVO)

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Nov 19, 2020
Registry last updated
May 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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