A Phase I Trial of a Single Intravitreal Injection of REDD14NP to Patients With CNV Secondary to Wet AMD - Full Text View

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

Genetics Home Reference related topics:

X-linked juvenile retinoschisis

MedlinePlus related topics:

Macular Degeneration

U.S. FDA Resources

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")

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:

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

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

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

Keywords provided by Quark Pharmaceuticals:

AMD

Study placed in the following topic categories:

Metaplasia

Eye Diseases

Choroid Diseases

Neoplasm Metastasis

Retinal Degeneration

Macular Degeneration

Neovascularization, Pathologic

Retinal Diseases

Retinal degeneration

Choroidal Neovascularization

Additional relevant MeSH terms:

Uveal Diseases

Pathologic Processes

ClinicalTrials.gov processed this record on October 21, 2008

Sponsored by:	Quark Pharmaceuticals
Information provided by:	Quark Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00455481