Diabetic Macular Edema
Conditions
Keywords
Diabetic Macular Edema
Brief summary
A Phase 1 Study to evaluate the Safety of teprotumumab in Patients with Diabetic Macular Edema.
Detailed 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).
Interventions
DRUGTeprotumumab
Teprotumumab 20mg/kg administered by intravenous infusion every 3 weeks for 3 infusions
Sponsors
Amgen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety of RV001in subjects with Diabetic Macular Edema | Change from Baseline to Week 9 | Number of subjects with adverse events, serious adverse events and early discontinuations due to adverse events. Number of subjects with clinical significant abnormal laboratory values, electrocardiograms (pre and post infusions), abnormal vital signs, ophthalmic and physical examinations. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety of RV001in subjects with Diabetic Macular Edema | Change from Baseline to Week 9 | Pharmacodynamic measure includes change in Optical Coherence Tomography, Fluorescein Angiography and Stereoscopic color funds photos findings. |
Countries
United States
Outcome results
None listed