Study of PF-04523655 (REDD14NP) In Subjects With Choroidal Neovascularization (CNV) Secondary to Age-Related Macular Degeneration (Wet AMD)
This study has been completed.
Sponsor:
Quark Pharmaceuticals
Collaborator:
Pfizer
Information provided by (Responsible Party):
Quark Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00725686
First received: July 28, 2008
Last updated: October 5, 2012
Last verified: October 2012
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | July 28, 2008 | ||||
| Last Updated Date | October 5, 2012 | ||||
| Start Date ICMJE | February 2007 | ||||
| Primary Completion Date | November 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
To determine the safety and tolerability of PF-04523655 when administered as a single intravitreal injection [ Time Frame: Over a 24-Month Period ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE |
To determine the safety and tolerability of PF-04523655 when administered as a single intravitreal injection [ Time Frame: Monthly ] [ Designated as safety issue: Yes ] | ||||
| Change History | Complete list of historical versions of study NCT00725686 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Study of PF-04523655 (REDD14NP) In Subjects With Choroidal Neovascularization (CNV) Secondary to Age-Related Macular Degeneration (Wet AMD) | ||||
| Official Title ICMJE | A Phase I 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 | The aim of the study is to evaluate whether PF-04523655 is safe in the treatment of neovascular/wet AMD |
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| Detailed Description | Dose escalation safety study |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 1 | ||||
| Study Design ICMJE | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Age-Related Macular Degeneration | ||||
| Intervention ICMJE | Drug: PF-04523655
This is a dose-escalation study (50, 100, 200, 400, 670, 1000, 1500, 2250, 3000 microgram) given at baseline and then the subject is followed up for 24 months
Other Name: REDD14NP |
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| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 54 | ||||
| Completion Date | November 2010 | ||||
| Primary Completion Date | November 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 50 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States, Israel | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00725686 | ||||
| Other Study ID Numbers ICMJE | B0451008, QRK.003 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Quark Pharmaceuticals | ||||
| Study Sponsor ICMJE | Quark Pharmaceuticals | ||||
| Collaborators ICMJE | Pfizer | ||||
| Investigators ICMJE |
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| Information Provided By | Quark Pharmaceuticals | ||||
| Verification Date | October 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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