Intravitreal Pegaptanib in Treatment of Choroidal Neovascularisation Secondary to Pathologic Myopia

Not Applicable

Withdrawn

• Conditions: Myopic Choroidal Neovascular Membrane
• Interventions: Drug: Intravitreal Pegaptanib

• Registration Number: NCT01218230
• Lead Sponsor: L.V. Prasad Eye Institute

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 Timeline

• Study First Submitted: 2010-10-08
• Study First Submitted QC: 2010-10-08
• Study First Posted: 2010-10-11
• Study Start: 2010-12
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-01
• Last Update Posted: 2015-09-02

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intravitreal Pegaptanib	Intravitreal Pegaptanib	-

Primary Outcome Measures

Name	Time	Method
Visual Acuity	12 months	Mean change in visual acuity from baseline to 54 weeks as measured by ETDRS chart

Secondary Outcome Measures

Name	Time	Method
Mean change in macular thickness on OCT from baseline to 54 weeks	12 months

Trial Locations

Locations (1)

LV Prasad Eye Institute; 🇮🇳 Hyderabad, AP, India