Intravitreal Pegaptanib in Treatment of Choroidal Neovascularisation Secondary to Pathologic Myopia
NCT01218230
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
1. Should be willing to participate in the trial.
2. Age less than 55 years.
3. Best corrected visual acuity (BCVA) score of at least 5 letters (20/200), as assessed by ETDRS chart.
4. Myopia of ≥ 6 Diopters.
5. Fluorescein angiographic documentation of CNV.
1. Ocular causes, or other ocular disorders leading to vision loss.
2. Maculopathy not related to pathologic myopia.
3. Pregnancy, lactation.
4. Not willing to provide an informed consent.
5. History of previous macular laser including PDT.
6. Other forms of therapy including intravitreal injections.
7. History of intraocular surgery in the past 3 months.
8. Anticipated cataract surgery in the next 6 months.
9. Any active infection or inflammation in the eye.
10. Cases where good quality imaging is not possible, either due to hazy media or
extremely high myopia.
11. Patients with uncontrolled glaucoma, with IOP > 21mm Hg on 2 or more medications.
12. Patients with subfoveal scar or significant subretinal haemorrhage occupying more than
50% of lesion size.
13. Eyes with previous retinal detachment.
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
- Hyderabad, AP
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 | |||
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. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Not Applicable | |||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
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 | |||
Study Arms ICMJE | Active Comparator: Intravitreal Pegaptanib
Intervention: Drug: Intravitreal Pegaptanib | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Withdrawn | |||
Actual Enrollment ICMJE | 0 | |||
Original Estimated Enrollment ICMJE | 20 | |||
Estimated Study Completion Date ICMJE | July 2012 | |||
Estimated Primary Completion Date | July 2012 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | India | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01218230 | |||
Other Study ID Numbers ICMJE | LEC08205 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Raja Narayanan, L.V. Prasad Eye Institute | |||
Study Sponsor ICMJE | L.V. Prasad Eye Institute | |||
Collaborators ICMJE | Pfizer | |||
Investigators ICMJE |
| |||
PRS Account | L.V. Prasad Eye Institute | |||
Verification Date | September 2015 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |