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

A First-in-human, Open-label, Single Ascending Dose Study to Assess Safety and Tolerability of Intravitreal MHU650 in Patients With Macular Edema

ClinicalTrials.gov Identifier: NCT04635800

Novartis Reference Number: CMHU650A12101

Last Update: Jan 18, 2022

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

This open-label study is being conducted to evaluate the initial safety and tolerability of IVT MHU650 in patients with DME, AMD, or RVO. The primary objective of this study is to evaluate the safety and tolerability of single ascending doses of IVT MHU650 in patients with macular edema. The secondary objective of this study is to evaluate the serum pharmacokinetic profile of total MHU650 following single IVT dose of MHU650 in macular edema patients.

Condition 
Macular Edema
Diabetic Macular Edema
Neovascular Age-related Macular Degeneration
Retinal Vein Occlusion
Phase 
Phase 1
Overall status 
Recruiting
Start date 
Dec 10, 2020
Completion date 
Mar 25, 2022
Gender 
All
Age(s)
18 Years - 90 Years (Adult, Older Adult)

Interventions

Drug
MHU650
MHU650 powder for solution for injection

Eligibility Criteria

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 (AMD), or retinal vein occlusion (RVO), in the opinion of the investigator:
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.
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:

- Proliferative diabetic retinopathy in the study eye

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

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

Other protocol-defined inclusion/exclusion criteria may apply

Study Locations

United States
Novartis Investigative Site
Recruiting
Huntington Beach, 92647
California
United States
Novartis Investigative Site
Recruiting
Irvine, 92697
California
United States
Novartis Investigative Site
Recruiting
Rancho Cordova, 95670
California
United States
Novartis Investigative Site
Recruiting
Altamonte Springs, 32701
Florida
United States
Novartis Investigative Site
Recruiting
Deerfield Beach, 33064
Florida
United States
Novartis Investigative Site
Recruiting
Honolulu, 96813
Hawaii
United States
Novartis Investigative Site
Recruiting
Hagerstown, 21740
Maryland
United States
Novartis Investigative Site
Recruiting
Austin, 78793
Texas
United States
Novartis Investigative Site
Recruiting
Houston, 77030
Texas
United States
Puerto Rico
Novartis Investigative Site
Recruiting
Arecibo, 00612
-
Puerto Rico

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 

Have a question?

Call 1-888-669-6682 or email [email protected]