Intravitreal Pegaptanib in Treatment of Choroidal Neovascularisation Secondary to Pathologic Myopia (INGECT)

L.V. Prasad Eye Institute

Status: Withdrawn

Conditions: Myopic Choroidal Neovascular Membrane

Treatments: Drug: Intravitreal Pegaptanib

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01218230

LEC08205

Details and patient eligibility

About

Intravitreal pegaptanib for treatment of choroidal neovascularisation secondary to pathologic myopia

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Intravitreal Pegaptanib

Active Comparator group

Treatment:

Drug: Intravitreal Pegaptanib