| ID | Type | Description | Link |
|---|---|---|---|
| QRK.003 | Other Identifier | Quark Pharmaceuticals Inc. |
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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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The aim of the study is to evaluate whether PF-04523655 is safe in the treatment of neovascular/wet AMD
Dose escalation safety study
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-04523655 | Drug | 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| To determine the safety and tolerability of PF-04523655 when administered as a single intravitreal injection | Over a 24-Month Period |
| Measure | Description | Time Frame |
|---|---|---|
| To describe anatomical changes in the retina and choroid following the administration of PF-04523655 | Day 14 | |
| To determine the changes in visual acuity ETDRS chart after a single intravitreal injection of PF-04523655 | Day 14 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Beverly Hills | California | 90211 | United States | ||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| To evaluate the safety, efficacy and frequency of dosing following administration of PF-04523655 of approved VEGF-inhibitors in those study patients requiring rescue therapy | Monthly |
| To evaluate early response after a single intravitreal administration of PF-04523655 in patients who, in the opinion of the investigator, have the potential to show improvement in visual acuity from other treatment options (Stratum 2 patients) | Day 14 |
| Pasadena |
| California |
| 91105 |
| United States |
| Pfizer Investigational Site | Walnut Creek | California | 94598 | United States |
| Pfizer Investigational Site | Miami | Florida | 33136 | United States |
| Pfizer Investigational Site | ‘Aiea | Hawaii | 96701 | United States |
| Pfizer Investigational Site | Baltimore | Maryland | 21205 | United States |
| Pfizer Investigational Site | New York | New York | 10022 | United States |
| Pfizer Investigational Site | Cleveland | Ohio | 44195 | United States |
| Pfizer Investigational Site | Tel Aviv | Israel | 64239 | Israel |
| Pfizer Investigational Site | Petah Tikva | 49100 | Israel |
| Pfizer Investigational Site | Rehovot | 76100 | Israel |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D020256 | Choroidal Neovascularization |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D015862 | Choroid Diseases |
| D014603 | Uveal Diseases |
| D009389 | Neovascularization, Pathologic |
| D008679 | Metaplasia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C576360 | PF-04523655 |
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