A Phase 1, Open-Label Study of Teprotumumab in Patients With Diabetic Macular Edema (DME)

Amgen

Status and phase

Completed

Phase 1

Conditions

Diabetic Macular Edema

Treatments

Drug: Teprotumumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT02103283

DME01RV

Details and patient eligibility

About

A Phase 1 Study to evaluate the Safety of teprotumumab in Patients with Diabetic Macular Edema.

Full description

A Phase 1, Open-Label Safety and Pharmacodynamic Study of RV 001, an Insulin-Like Growth Factor-1 Receptor (IGF-1) Antagonist, Given By IV Infusion in Patients with Diabetic Macular Edema (DME).

Enrollment

5 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Diagnosis of diabetes mellitus with Hemoglobin A1c <8.5%
IGF 1 in serum > 106 ng/mL
Women of child-bearing potential must have negative pregnancy test and be willing and able to use two different methods of contraception, one of which must be oral contraceptive or depot formulation. Males must be surgically sterile or agree to use barrier contraception
Clinically significant DME of less than 12 months duration
Non-proliferative diabetic retinopathy of moderate severity
Best corrected electronic ETDRS letter score < 78 and > 24

Exclusion criteria

Unstable-uncontrolled diabetes as demonstrated by a change in diabetes medication greater than 15% in the previous 60 days.
Significant renal disease, myocardial infarction, stroke, transient ischemic attack, acute congestive heart failure
Blood pressure > 180/110
Anti-vascular endothelial growth factor (VEGF) treatment within two months prior to enrollment
History of pan retinal photocoagulation within four months prior to enrollment
History of ocular surgery within four months prior to enrollment
History of systemic treatment with corticosteroids within 3 months prior to enrollment