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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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The purpose of this study is to assess the efficacy of pegaptanib (Macugen®) for neovascular (exudative) age-related macular degeneration (AMD) when the first dose is administered to the submacular space instead of vitreous body in cases when previous state-of-the-art treatment for the AMD was deemed ineffective.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pegaptanib (Macugen®) | Drug | Pegaptanib administered to the subretinal space (first dose) and to the vitreous cavity (following doses) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients who had lost fewer than 15 letters of visual acuity at 54 weeks | 54 weeks | |
| Mean change from baseline in total size of lesion and total size of CNV at 12, 24 and 54 weeks | week 24 and 54 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in best corrected visual acuity (BCVA) from baseline at 54 weeks | 54 weeks | |
| Mean change from baseline in at week 12 and 24 | week 12 and 24 | |
| Proportion of patients who gain ≥ 5, 10, 15 letters of BCVA from baseline at week 24 and 54 |
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Inclusion Criteria:
Exclusion Criteria:
Subjects presenting with any of the following criteria will not be included in the trial:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lars-Olof Hattenbach, MD | Contact | +49 (621) 503 3051 | hattenbl@klilu.de |
| Name | Affiliation | Role |
|---|---|---|
| Lars-Olof Hattenbach, MD | Department of ophthalmology, Ludwigshafen hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Ophthalmology, Ludwigshafen hospital | Recruiting | Ludwigshafen | 67063 | Germany |
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| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C495058 | pegaptanib |
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| week 24 and 54 |
| Proportion of patients who lose less than 15 letters of BCVA from baseline at week 24 and 54 | week 24 and 54 |
| Change in area of leakage at 12, 24 and 54 weeks | weeks 12, 24 and 54 |
| Mean change in retinal thickness by OCT at center of fovea at 12, 24 and 54 weeks | weeks 12, 24 and 54 |