Intravitreal Pegaptanib in Treatment of Choroidal Neovascularisation Secondary to Pathologic Myopia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2012-07-31

Brief Summary

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Intravitreal pegaptanib for treatment of choroidal neovascularisation secondary to pathologic myopia

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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.

Conditions

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Myopic Choroidal Neovascular Membrane

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intravitreal Pegaptanib

Group Type ACTIVE_COMPARATOR

Intravitreal Pegaptanib

Intervention Type DRUG

Intravitreal pegaptanib, 0.3 mg, every 6 weeks for 3 injections and then PRN.

Interventions

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Intravitreal Pegaptanib

Intravitreal pegaptanib, 0.3 mg, every 6 weeks for 3 injections and then PRN.

Intervention Type DRUG

Other Intervention Names

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Macugen

Eligibility Criteria

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Inclusion Criteria

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.

Exclusion Criteria

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No