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

September 1, 2015 updated by: Raja Narayanan, L.V. Prasad Eye Institute

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

Intravitreal pegaptanib for treatment of choroidal neovascularisation secondary to pathologic myopia

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • AP
      • Hyderabad, AP, India, 500034
        • LV Prasad Eye Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Intravitreal Pegaptanib
Drug: Intravitreal Pegaptanib
Intravitreal pegaptanib, 0.3 mg, every 6 weeks for 3 injections and then PRN.
Other Names:
  • Macugen

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Acuity
Time Frame: 12 months
Mean change in visual acuity from baseline to 54 weeks as measured by ETDRS chart
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Mean change in macular thickness on OCT from baseline to 54 weeks
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

L.V. Prasad Eye Institute

Collaborators

Pfizer

Investigators

  • Principal Investigator: Raja Narayanan, MD, LV Prasad Eye Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2010

Primary Completion (Anticipated)

July 1, 2012

Study Completion (Anticipated)

July 1, 2012

Study Registration Dates

First Submitted

October 8, 2010

First Submitted That Met QC Criteria

October 8, 2010

First Posted (Estimate)

October 11, 2010

Study Record Updates

Last Update Posted (Estimate)

September 2, 2015

Last Update Submitted That Met QC Criteria

September 1, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LEC08205

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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