Myopic Choroidal Neovascular Membrane
Conditions
Keywords
Pegaptanib, myopic CNVM, intravitreal anti-VEGF
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.
Interventions
Intravitreal pegaptanib, 0.3 mg, every 6 weeks for 3 injections and then PRN.
Sponsors
Pfizer
L.V. Prasad Eye Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Acuity | 12 months | Mean change in visual acuity from baseline to 54 weeks as measured by ETDRS chart |
Secondary
| Measure | Time frame |
|---|---|
| Mean change in macular thickness on OCT from baseline to 54 weeks | 12 months |
Countries
India
Outcome results
None listed