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A Phase I Trial of a Single Intravitreal Injection of REDD14NP to Patients With CNV Secondary to Wet AMD
This study is currently recruiting participants.
Verified by Quark Pharmaceuticals, October 2007
First Received: March 30, 2007   Last Updated: October 30, 2007   History of Changes
Sponsor: Quark Pharmaceuticals
Information provided by: Quark Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00455481
  Purpose

This is an open-label, dose escalation study in which patents will receive a single intravitreal injection of REDD14NP. The primary objective of the study is to determine the safety and pharmacokinetics of REDD14NP when administered as a single intravitreal injection.


Condition Intervention Phase
Age-Related Macular Degeneration (AMD)
 Drug: REDD14NP
 Phase I

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title: A Phase 1 Open-Label, Dose Escalation Trial of REDD14NP Delivered by a Single Intravitreal Injection to Patients With Choroidal Neovascularization (CNV) Secondary to Exudative Age-Related Macular Degeneration ("Wet AMD")

Resource links provided by NLM:

Genetics Home Reference related topics: X-linked juvenile retinoschisis
MedlinePlus related topics: Macular Degeneration
U.S. FDA Resources

Further study details as provided by Quark Pharmaceuticals:

Primary Outcome Measures:
  • Safety [ Time Frame: 12 weeks ]
  • Dose-limiting toxicities (DLT) [ Time Frame: 30 days ]
  • Pharmacokinetics [ Time Frame: 14 days ]

Secondary Outcome Measures:
  • Anatomical changes in the retina and choroid [ Time Frame: 84 days ]
  • Changes in visual acuity [ Time Frame: 84 days ]

Estimated Enrollment: 42
Study Start Date: February 2007
Estimated Study Completion Date: December 2009
Intervention Details:
    Drug: REDD14NP
    Single intravitreal injection of REDD14NP.
  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • documented CNV (all subtypes) secondary to AMD
  • must be able to give consent and comply with study visit schedule
  • clear ocular media and adequate pupil dilation
  • intravitreal pressure <= 25 mmHg.
  • retinal thickness > 250 um by OCT
  • best corrected vision not better than 20/200

Exclusion Criteria:

  • women of childbearing potential
  • CNV due to causes other than AMD
  • underlying disease or other disease of the eye
  • therapy (including experimental) for AMD in the study eye in last 30 days
  • any concurrent other interventional study
  • steroid therapy for AMD in last six months
  • history of intraocular surgery other than cataract surgery
  • history of retinal detachment in the study eye
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00455481

Locations
United States, California
Bay Area Retina Associates Recruiting
Walnut Creek, California, United States, 94598
Contact: Kathleen Dowell     925-943-6800     kdowell@bayarearetina.com    
Principal Investigator: Daniel Ting, M.D.            
Retina Institute of California Recruiting
Pasadena, California, United States, 91105
Contact: Alexadra Tran     626-568-8838     alexandra.tran@hotmail.com    
Principal Investigator: Tom S. Chang, M.D.            
United States, Florida
Bascom Palmer Eye Institute, University of Miami Recruiting
Miami, Florida, United States, 33136
Contact: Cristina M. Lage, M.S.     305-326-6117     clage@med.miami.edu    
Principal Investigator: Philip J Rosenfeld, MD, PhD            
United States, New York
Vitreous Retina Macula Consultants of New York Recruiting
New York, New York, United States, 10022
Contact: Peggy Guerrero     212-861-9797     pguerrero@vrmny.com    
Principal Investigator: James M Klancnik, MD            
United States, Ohio
Cole Eye Institute Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Contact: Lynn Bartko, RN, BSN     216-444-7137     bartkol@ccf.org    
Principal Investigator: Peter K Kaiser, MD            
United States, Washington
Retina Center NW Recruiting
Silverdale, Washington, United States, 98383
Contact: Jackie Gaedke     360-307-0300     jackie@retinacenternw.com    
Principal Investigator: Todd E. Schneiderman, M.D.            
Israel
Rabin Medical Center Recruiting
Petah Tikva, Israel, 49100
Contact: Vivi Dagan     972-3-9377199     eyeclinic@clalit.org.il    
Principal Investigator: Irit Rosenblatt, M.D.            
Kaplan Medical Center Recruiting
Rehovot, Israel, 76100
Contact: Anat Pilpul     972-8-9441353     apilpoul@yahoo.com    
Principal Investigator: Ayala Pollack, M.D.            
Tel Aviv Sourasky Medical Center Recruiting
Tel Aviv, Israel, 64239
Contact: Roselyn Halpern     972-3-6974361     o-research@tasmc.health.gov.il    
Principal Investigator: Michaella Goldstein, M.D.            
Sponsors and Collaborators
Quark Pharmaceuticals
Investigators
Principal Investigator: James M Klancnik, MD Vitreous -Retina- Macula Consultants of New York
  More Information

Additional Information:
Quark Biotech, Inc.  This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers: QRK.003
Study First Received: March 30, 2007
Last Updated: October 30, 2007
ClinicalTrials.gov Identifier: NCT00455481     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Quark Pharmaceuticals:
AMD

Additional relevant MeSH terms:
Uveal Diseases
Pathologic Processes
Metaplasia
Eye Diseases
Choroid Diseases
 Retinal Degeneration
Macular Degeneration
Neovascularization, Pathologic
Retinal Diseases
Choroidal Neovascularization

ClinicalTrials.gov processed this record on November 30, 2009



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