A Clinical Trial to Study the Efficacy and Safety of Intravitreal Pegaptanib in Treatment of Choroidal Neovascularisation Secondary to Pathologic Myopia
Overview
- Phase
- Not Applicable
- Intervention
- Intravitreal Pegaptanib
- Conditions
- Myopic Choroidal Neovascular Membrane
- Sponsor
- L.V. Prasad Eye Institute
- Locations
- 1
- Primary Endpoint
- Visual Acuity
- Status
- Withdrawn
- Last Updated
- 10 years ago
Overview
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.
Investigators
Raja Narayanan
Head of Clinical Research
L.V. Prasad Eye Institute
Eligibility Criteria
Inclusion Criteria
- •Should be willing to participate in the trial.
- •Age less than 55 years.
- •Best corrected visual acuity (BCVA) score of at least 5 letters (20/200), as assessed by ETDRS chart.
- •Myopia of ≥ 6 Diopters.
- •Fluorescein angiographic documentation of CNV.
Exclusion Criteria
- •Ocular causes, or other ocular disorders leading to vision loss.
- •Maculopathy not related to pathologic myopia.
- •Pregnancy, lactation.
- •Not willing to provide an informed consent.
- •History of previous macular laser including PDT.
- •Other forms of therapy including intravitreal injections.
- •History of intraocular surgery in the past 3 months.
- •Anticipated cataract surgery in the next 6 months.
- •Any active infection or inflammation in the eye.
- •Cases where good quality imaging is not possible, either due to hazy media or extremely high myopia.
Arms & Interventions
Intravitreal Pegaptanib
Intervention: Intravitreal Pegaptanib
Outcomes
Primary Outcomes
Visual Acuity
Time Frame: 12 months
Mean change in visual acuity from baseline to 54 weeks as measured by ETDRS chart
Secondary Outcomes
- Mean change in macular thickness on OCT from baseline to 54 weeks(12 months)