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The objectives of this study are to evaluate the safety and efficacy of 3 dose groups (27, 36 and 45 mg/m2) of Combretastatin A-4 Phosphate for the treatment of subfoveal choroidal neovascularization in subjects with pathologic myopia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 36 mg/m2 Combretastin A-4 Phosphate | Experimental |
| |
| 45 mg/m2 Combretastatin A-4 Phosphate | Experimental |
| |
| 27 mg/m2 Combretastatin A-4 Phosphate | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Combretastatin A-4 Phosphate | Drug | Combretastatin A-4 Phosphate is administered on Day 0 and Day 7 (+/- 2 days). If the treating ophthalmologist notes any leakage from CNV in the study eye on a fluorescein angiography during the study or an increase in subretinal fluid on an optical coherence tomography measurement, retreatment with Combretastatin A-4 Phosphate is recommended with up to 3 additional treatments. The retreatment visit(s) could occur during a scheduled visit or at an additional visit 1 week after a regular study visit. A post-retreatment follow-up visit is necessary. |
| Measure | Description | Time Frame |
|---|---|---|
| Visual acuity line change from baseline at 3-month following | from baseline to 3 months | |
| Visual acuity response category at 3-month follow-up | from baseline to 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Visual acuity line change from baseline at 1 month follow-up | from baseline to 1 month | |
| Visual acuity response category at 1 month follow-up | from baseline to 1 month | |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37816266 | Derived | Giri P, Batra PJ, Kumari A, Hura N, Adhikary R, Acharya A, Guchhait SK, Panda D. Development of QTMP: A promising anticancer agent through NP-Privileged Motif-Driven structural modulation. Bioorg Med Chem. 2023 Nov 15;95:117489. doi: 10.1016/j.bmc.2023.117489. Epub 2023 Oct 5. |
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|
|
| Number of patients with treatment emergent adverse events |
| from first dose of study drug to 30 days after last dose of study drug |
| ID | Term |
|---|---|
| D020256 | Choroidal Neovascularization |
| D047728 | Myopia, Degenerative |
| ID | Term |
|---|---|
| D015862 | Choroid Diseases |
| D014603 | Uveal Diseases |
| D005128 | Eye Diseases |
| D009389 | Neovascularization, Pathologic |
| D008679 | Metaplasia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009216 | Myopia |
| D012030 | Refractive Errors |
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| ID | Term |
|---|---|
| C058728 | fosbretabulin |
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