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MHU650 for macular edema from DME, nAMD or RVO

Andrew Browne


A Study On:

  • Other

Status:

  • Open

Eligibility

Macular Edema
Diabetic Macular Edema
Neovascular Age-related Macular Degeneration
Retinal Vein Occlusion

18 Years to 90 Years (Adult, Older Adult)

Interested in joining this trial?

Official 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)

Details

This is an open-label, multi-center, FIH study which employs a single ascending dose (SAD) design to assess the safety, tolerability and pharmacokinetics (PK) of single IVT doses of MHU650 in up to 24 patients with macular edema. 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) during which ophthalmic, medical and safety laboratories will be performed. A post study safety phone contact call will occur 30 days after the EOS visit. Patients can receive rescue treatment at any time during the study following MHU650 administration.


Eligibility

You can join if...

Key Inclusion Criteria:

  1. Patients with macular edema in at least one eye, including those with focal or diffuse diabetic macular edema (DME), neovascular age-related macular degeneration (AMD), or retinal vein occlusion (RVO), in the opinion of the investigator:
  2. Early Treatment Diabetic Retinopathy (ETDRS) letter score in the study eye must be worse than 60 letters (20/63) but better than 24 letters (20/320) at screening and baseline. The ETDRS score in the non-study eye should be ≥ 60 letters at screening and baseline.
  3. Sufficiently clear ocular media and adequate pupil dilation to permit fundus photographs of adequate clarity to measure diameters of retinal arteries and veins
  4. Vital signs as specified in the protocol

Key Exclusion Criteria:

  1. Proliferative diabetic retinopathy in the study eye
  2. The following is permitted as an exception:
    • Tufts of neovascularization less than one disc area with no vitreous hemorrhage
    • Focal, peripheral retinal areas treated with photocoagulation with fewer than 30 laser burns performed at least 6 months preceding Day 1
  3. Patients with type 1or type 2 diabetes who have hemoglobin A1C of ≥ 12 at screening
  4. Other ocular conditions as specified in the protocol
  5. Systemic conditions as specified in the protocol
  6. Other protocol-defined inclusion/exclusion criteria may apply

Get in touch with our study team