Safety and Efficacy Study of Combretastatin A4 Phosphate to Treat Patients With Choroidal Neovasc… (NCT01423149) | Clinical Trial Compass
CompletedPhase 2
Safety and Efficacy Study of Combretastatin A4 Phosphate to Treat Patients With Choroidal Neovascularization Secondary to Pathologic Myopia
23 participantsStarted 2005-03
Plain-language summary
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.
Who can participate
Age range18 Years – 50 Years
SexALL
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Inclusion Criteria:
* Provide written informed consent
* Be able and willing to follow instructions
* Age 18 to 50 years old (inclusive)
* Have area of CNV within 50 um or under the geometric center of the foveal avascular zone Have greatest linear dimension of lesion 5,400 um or less, with \>/=50.0% of the lesion composed of CNV (features which obscure the boundaries of the CNV such as blood, serous pigment epithelial detachment or blocked fluorescence must occupy \<50.0%) as confirmed by Doheny Image Reading Center (DIRC)
* Have best corrected distance visual acuity (ETDRS) of 20/20 to 20/200 (LogMAR +0.0 to 1.0), inclusive in the qualifying eye(s)
* Have pathologic myopia presenting - 6.0 diopters or more correction required OR an axial length of the \>/= 26.5 mm
* Be able and willing to avoid any medication that the investigator feels may interfere with the study
* If female and of childbearing potential, agree to submit a sample for pregnancy testing and have a negative pregnancy test within 1 day prior to each treatment. Females are considered of childbearing potential unless they are surgically sterile or post-menopausal for 12 months. Females of childbearing potential must agree to an approved form of contraception for the duration of the study.
Exclusion Criteria:
* Have contraindications, allergies or sensitivity to the use of the study medications
* Have clinical signs or symptoms, in the opinion of the investigator, that may interfere with the study
* Features …
What they're measuring
1
Visual acuity line change from baseline at 3-month following
Timeframe: from baseline to 3 months
2
Visual acuity response category at 3-month follow-up