Intravitreal Pegaptanib in Treatment of Choroidal Neovascularisation Secondary to Pathologic Myopia

Study Overview
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Brief Summary
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Intravitreal pegaptanib for treatment of choroidal neovascularisation secondary to pathologic myopia

Detailed Description
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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.

Official Title
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A Clinical Trial to Study the Efficacy and Safety of Intravitreal Pegaptanib in Treatment of Choroidal Neovascularisation Secondary to Pathologic Myopia

Conditions
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Myopic Choroidal Neovascular Membrane

Intervention / Treatment
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* Drug: Intravitreal Pegaptanib


Participation Criteria
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Eligibility Criteria
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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. Patients with uncontrolled glaucoma, with IOP > 21mm Hg on 2 or more medications. Patients with subfoveal scar or significant subretinal haemorrhage occupying more than 50% of lesion size. Eyes with previous retinal detachment.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intravitreal Pegaptanib<br> | Drug: Intravitreal Pegaptanib<br>* Intravitreal pegaptanib, 0.3 mg, every 6 weeks for 3 injections and then PRN.<br>* Other names: Macugen;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Acuity | Mean change in visual acuity from baseline to 54 weeks as measured by ETDRS chart | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in macular thickness on OCT from baseline to 54 weeks |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pegaptanib, myopic CNVM, intravitreal anti-VEGF