Safety and Efficacy Study of Combretastatin A4 Phosphate to Treat Patients With Choroidal Neovascularization Secondary to Pathologic Myopia
This study has been completed.
Sponsor:
OXiGENE
Information provided by (Responsible Party):
OXiGENE
ClinicalTrials.gov Identifier:
NCT01423149
First received: August 22, 2011
Last updated: October 28, 2011
Last verified: October 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Choroidal Neovascularization Myopia, Degenerative |
Drug: Combretastatin A-4 Phosphate |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Phase II, Dose Ranging, Multi-Center Study to Evaluate the Safety and Efficacy of Combretastatin A4 Phosphate for Treating Subfoveal Choroidal Neovascularization in Subjects With Pathologic Myopia |
Further study details as provided by OXiGENE:
Primary Outcome Measures:
- Visual acuity line change from baseline at 3-month following [ Time Frame: from baseline to 3 months ] [ Designated as safety issue: No ]
- Visual acuity response category at 3-month follow-up [ Time Frame: from baseline to 3 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Visual acuity line change from baseline at 1 month follow-up [ Time Frame: from baseline to 1 month ] [ Designated as safety issue: No ]
- Visual acuity response category at 1 month follow-up [ Time Frame: from baseline to 1 month ] [ Designated as safety issue: No ]
- Number of patients with treatment emergent adverse events [ Time Frame: from first dose of study drug to 30 days after last dose of study drug ] [ Designated as safety issue: Yes ]
| Enrollment: | 23 |
| Study Start Date: | March 2005 |
| Study Completion Date: | January 2007 |
| Primary Completion Date: | January 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 36 mg/m2 Combretastin A-4 Phosphate |
Drug: Combretastatin A-4 Phosphate
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.
Other Names:
|
| Experimental: 45 mg/m2 Combretastatin A-4 Phosphate |
Drug: Combretastatin A-4 Phosphate
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.
Other Names:
|
| Experimental: 27 mg/m2 Combretastatin A-4 Phosphate |
Drug: Combretastatin A-4 Phosphate
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.
Other Names:
|
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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 of any condition other than pathologic myopia associated with CNV, such as age-related macular degeneration
- Have a tear of the retinal pigmented epithelium
- Have undergoing ocular therapy/surgery or major surgery in the last 3 months or have any surgeries planned during the study period
- Have any significant illness or condition, ocular or systemic that could, in the opinion of the investigator, be expected to interfere with the study
- Have angina (stable or severe, even if controlled with medications), 6 months S/P myocardial infarction ,congestive heart failure, history of or presence of any clinically significant supraventricular or ventricular arrhythmias or syncope episodes
- Have ECG with QTc >450 msdec or other clinically significant abnormalities such as left bundle branch block, left ventricular hypertrophy, etc.
- Have uncontrolled QTc prolongation
- Take any drugs known to prolong the QTc interval however subject can remain eligible if a non-QTc substitute can be administered
- Have uncontrolled hypertension (defined as blood pressure consistently greater than 150/100 mm Hg irrespective of medication)
- Uncontrolled hypokalemia and/or hypomagnesemia
- Have symptomatic peripheral vascular disease or cerebrovascular disease
- Have psychiatric disorders or other conditions rendering subjects incapable of complying with the requirements of the protocol
- Be receiving concurrent hormonal therapy with exception of Gonadotropin-releasing hormone agonists in subjects with hormone refractory prostate cancer, hormone replacement therapy, oral contraceptive, and megestrol acetate used for anorexia/cachexia
- Be receiving anticoagulation with warfarin, heparin or low molecular weight heparin other than low dose (1 mg) warfarin for maintenance of Hickman line patency
- Be a woman who is currently pregnant, nursing, or planning a pregnancy; or woman who has a positive pregnancy test
- Have participated in an investigational drug or device trial within 30 days of entering the study
Contacts and Locations
No Contacts or Locations Provided
More Information
No publications provided
| Responsible Party: | OXiGENE |
| ClinicalTrials.gov Identifier: | NCT01423149 History of Changes |
| Other Study ID Numbers: | MMD-213 |
| Study First Received: | August 22, 2011 |
| Last Updated: | October 28, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by OXiGENE:
|
subfoveal choroidal neovascularization pathologic myopia |
Additional relevant MeSH terms:
|
Myopia Neovascularization, Pathologic Myopia, Degenerative Choroidal Neovascularization Refractive Errors Eye Diseases Metaplasia Pathologic Processes Choroid Diseases Uveal Diseases |
Combretastatin Combretastatin A-4 Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 17, 2013