Intravitreal Pegaptanib in Treatment of Choroidal Neovascularisation Secondary to Pathologic Myopia (INGECT)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by L.V. Prasad Eye Institute.
Recruitment status was Not yet recruiting
Recruitment status was Not yet recruiting
Sponsor:
L.V. Prasad Eye Institute
Collaborator:
Pfizer
Information provided by:
L.V. Prasad Eye Institute
ClinicalTrials.gov Identifier:
NCT01218230
First received: October 8, 2010
Last updated: NA
Last verified: October 2010
History: No changes posted
| Tracking Information | |||||||||
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| First Received Date ICMJE | October 8, 2010 | ||||||||
| Last Updated Date | October 8, 2010 | ||||||||
| Start Date ICMJE | December 2010 | ||||||||
| Estimated Primary Completion Date | July 2012 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Visual Acuity [ Time Frame: 12 months ] [ Designated as safety issue: No ] Mean change in visual acuity from baseline to 54 weeks as measured by ETDRS chart |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures ICMJE |
Mean change in macular thickness on OCT from baseline to 54 weeks [ Time Frame: 12 months ] [ Designated as safety issue: No ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Intravitreal Pegaptanib in Treatment of Choroidal Neovascularisation Secondary to Pathologic Myopia | ||||||||
| Official Title ICMJE | A Clinical Trial to Study the Efficacy and Safety of Intravitreal Pegaptanib in Treatment of Choroidal Neovascularisation Secondary to Pathologic Myopia | ||||||||
| Brief Summary | Intravitreal pegaptanib for treatment of choroidal neovascularisation secondary to pathologic myopia |
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| Detailed Description | This is a Prospective Interventional, non-comparative study in 20 consecutive patients who will be selected from the outpatient services. After taking an informed consent, the patients will be given intravitreal Pegaptanib 0.3 mg every 6 weeks for 3 procedure of injection. Thereafter, patients will continue to be examined every 6 weeks (± 2 weeks) and of may receive additional injections as needed based on the presence of one or more re-treatment criteria (please see below). Final assessment will be done at 54 weeks and all the baseline investigations will be performed. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Myopic Choroidal Neovascular Membrane | ||||||||
| Intervention ICMJE | Drug: Intravitreal Pegaptanib
Intravitreal pegaptanib, 0.3 mg, every 6 weeks for 3 injections and then PRN.
Other Name: Macugen |
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| Study Arm (s) | Active Comparator: Intravitreal Pegaptanib
Intervention: Drug: Intravitreal Pegaptanib |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Not yet recruiting | ||||||||
| Estimated Enrollment ICMJE | 20 | ||||||||
| Estimated Completion Date | July 2012 | ||||||||
| Estimated Primary Completion Date | July 2012 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | India | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01218230 | ||||||||
| Other Study ID Numbers ICMJE | LEC08205 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Raja Narayanan, MD, LV Prasad Eye Institute | ||||||||
| Study Sponsor ICMJE | L.V. Prasad Eye Institute | ||||||||
| Collaborators ICMJE | Pfizer | ||||||||
| Investigators ICMJE |
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| Information Provided By | L.V. Prasad Eye Institute | ||||||||
| Verification Date | October 2010 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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