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

Tracking Information

First Received Date ^ICMJE

March 30, 2007

Last Updated Date

October 30, 2007

Start Date ^ICMJE

February 2007

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Safety
Dose-limiting toxicities (DLT)
Pharmacokinetics
Tolerability

Change History

Complete list of historical versions of study NCT00455481 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Anatomical changes in the retina and choroid
Changes in visual acuity

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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")

Brief Summary

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.

Detailed Description

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study

Condition ^ICMJE

Age-Related Macular Degeneration (AMD)

Intervention ^ICMJE

Drug: REDD14NP

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2009

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

50 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Location Countries ^ICMJE

United States, Israel

Administrative Information

NCT ID ^ICMJE

NCT00455481

Responsible Party

Study ID Numbers ^ICMJE

QRK.003

Study Sponsor ^ICMJE

Quark Pharmaceuticals

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

James M Klancnik, MD

Vitreous -Retina- Macula Consultants of New York

Information Provided By

Quark Pharmaceuticals

Verification Date

October 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP