Status:
COMPLETED
PF-04523655 Dose Escalation Study, and Evaluation of PF-04523655 With/Without Ranibizumab in Diabetic Macular Edema (DME)
Lead Sponsor:
Quark Pharmaceuticals
Conditions:
Choroidal Neovascularization
Diabetic Retinopathy
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a two-part study. The first part (Stratum I) is an open-label, dose escalation, safety, tolerability and pharmacokinetic study, where active study drug (PF-04523655) will be given to all patie...
Detailed Description
Patients will be enrolled concurrently according to one of two sets of criteria designated as Stratum I and Stratum II. 1. Stratum I will enroll up to 24 subjects with low vision, inclusive of possib...
Eligibility Criteria
Inclusion
- Key Stratum I
- Visual acuity in the study eye ≤ 20/200.
- Low visual acuity is the result of an irreversible condition affecting the posterior segment of the study eye.
- Key Stratum I
Exclusion
- History of vitrectomy.
- History of IVT injection in study eye within last 6 months.
- History of vitreous hemorrhage, retinal detachment, or invasive trauma in study eye.
- History of uveitis or endophthalmitis in either eye.
- Any active inflammatory condition in study eye.
- Received any drugs known to cause optic nerve or retinal toxicity within 14 days prior to dosing.
- Any medical condition, concomitant therapy or previous incisional or laser surgery that, in the opinion of the Investigator, would preclude IVT injection in the study eye.
- Intraocular pressure in either eye ≥25 mmHg on maximal medication.
- Cataract surgery and laser corneal surgery within 3 months prior to dosing in the study eye and all other intraocular surgeries at any time.
- Participation in a concurrent interventional study within 30 days prior to dosing.
- Key Stratum II Inclusion Criteria:
- History of diabetes mellitus (Type 1 or Type 2).
- Retinal thickening secondary to the edema caused by diabetes mellitus.
- Best corrected visual acuity (BCVA) of 20/40 or worse and up to 20/320 or better in the study eye at Screening.
- Standard of care treatment for DME can be withheld for at least 90 days after the subject has enrolled in the study (study eye only).
- Key Stratum II
Key Trial Info
Start Date :
February 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
258 Patients enrolled
Trial Details
Trial ID
NCT01445899
Start Date
February 1 2012
End Date
November 1 2013
Last Update
February 23 2015
Active Locations (51)
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1
Retina Consultants of Arizona
Phoenix, Arizona, United States, 85014
2
Retina Institute of California
Arcadia, California, United States, 91007
3
Retina-Vitreous Associates
Beverly Hills, California, United States, 90211
4
Retina Diagnostic Center
Campbell, California, United States, 95008