Choroidal NeovascularizationPhase 2NCT01423149
Safety and Efficacy Study of Combretastatin A4 Phosphate to Treat Patients With Choroidal Neovascularization Secondary to Pathologic Myopia
A Phase 2 study testing Combretastatin A-4 Phosphate in people with Choroidal Neovascularization and Myopia, Degenerative, run by Mateon Therapeutics.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Choroidal Neovascularization, Myopia, Degenerative
- What is being tested?
- Combretastatin A-4 Phosphate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- No sites listed yet
- Study dates
- Mar 2005to Jan 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 18Show fewer
- 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
About this study
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
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.
- Conditions
- Choroidal Neovascularization, Myopia, Degenerative
- Being tested
- Combretastatin A-4 Phosphate
- Keywords
- subfoveal choroidal neovascularization, pathologic myopia
- Medical subject headings
- Choroidal Neovascularization, Myopia, Degenerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combretastatin A-4 PhosphateDrug
Also called CA4P, fosbretabulin
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.
| Study group | Role | What they receive |
|---|---|---|
| 36 mg/m2 Combretastin A-4 Phosphate | Experimental | Not described Receives: Drug: Combretastatin A-4 Phosphate |
| 45 mg/m2 Combretastatin A-4 Phosphate | Experimental | Not described Receives: Drug: Combretastatin A-4 Phosphate |
| 27 mg/m2 Combretastatin A-4 Phosphate | Experimental | Not described Receives: Drug: Combretastatin A-4 Phosphate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual acuity line change from baseline at 3-month following
Measured: from baseline to 3 months
Visual acuity response category at 3-month follow-up
Measured: from baseline to 3 months
Secondary outcomes (3)
Visual acuity line change from baseline at 1 month follow-up
Measured: from baseline to 1 month
Visual acuity response category at 1 month follow-up
Measured: from baseline to 1 month
Number of patients with treatment emergent adverse events
Measured: from first dose of study drug to 30 days after last dose of study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2011 (estimated)
- Study startMar 2005
- Primary completionJan 2007
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Choroidal NeovascularizationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mateon Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01423149
- Sponsor's protocol ID
- MMD-213
- Status last verified
- Oct 2011
- First submitted
- 22 Aug 2011
- Last updated
- 1 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 37816266
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01423149
- Acronym / sponsor ID
- MMD-213
- Conditions
- Choroidal Neovascularization, Myopia, Degenerative
- Keywords
- subfoveal choroidal neovascularization, pathologic myopia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Mateon TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Mar 2005
- Primary completion
- Jan 2007 (actual)
- Study completion
- Jan 2007 (actual)
- First posted
- 25 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 36 mg/m2 Combretastin A-4 Phosphate | Experimental | Drug: Combretastatin A-4 Phosphate |
| 45 mg/m2 Combretastatin A-4 Phosphate | Experimental | Drug: Combretastatin A-4 Phosphate |
| 27 mg/m2 Combretastatin A-4 Phosphate | Experimental | Drug: Combretastatin A-4 Phosphate |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combretastatin A-4 PhosphateAlso: CA4P, fosbretabulinCombretastatin 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. | Drug | 27 mg/m2 Combretastatin A-4 Phosphate, 36 mg/m2 Combretastin A-4 Phosphate, 45 mg/m2 Combretastatin A-4 Phosphate |
Primary outcome
Visual acuity line change from baseline at 3-month following
Time frame: from baseline to 3 months
Visual acuity response category at 3-month follow-up
Time frame: from baseline to 3 months
3 secondary outcomes
Visual acuity line change from baseline at 1 month follow-up
Time frame: from baseline to 1 month
Visual acuity response category at 1 month follow-up
Time frame: from baseline to 1 month
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2011.
- Derived from this study: PubMed 37816266Giri 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Combretastatin A-4 Phosphate in people with Choroidal Neovascularization and Myopia, Degenerative, run by Mateon Therapeutics.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual acuity line change from baseline at 3-month following (time frame: from baseline to 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01423149, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2011.