Intravitreal Pegaptanib in Treatment of Choroidal Neovascularisation Secondary to Pathologic Myopia

Myopic Choroidal Neovascular Membrane Clinical Trial

— INGECT  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01218230
• Other study ID #: LEC08205
• Status: Withdrawn
• Phase: N/A
• First received: October 8, 2010
• Last updated: September 1, 2015
• Start date: December 2010
• Est. completion date: July 2012

Study information

• Verified date: September 2015
• Source: L.V. Prasad Eye Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

Intravitreal pegaptanib for treatment of choroidal neovascularisation secondary to pathologic myopia

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Choroidal Neovascularization
• Myopic Choroidal Neovascular Membrane
• Neovascularization, Pathologic

Intervention

Drug:
• Intravitreal Pegaptanib
Intravitreal pegaptanib, 0.3 mg, every 6 weeks for 3 injections and then PRN.

Locations

Country	Name	City	State
India	LV Prasad Eye Institute	Hyderabad	AP

Sponsors (2)

Lead Sponsor	Collaborator
L.V. Prasad Eye Institute	Pfizer

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Acuity	Mean change in visual acuity from baseline to 54 weeks as measured by ETDRS chart	12 months	No
Secondary	Mean change in macular thickness on OCT from baseline to 54 weeks		12 months	No