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

Primary Purpose

Myopic Choroidal Neovascular Membrane

Status
Withdrawn
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Intravitreal Pegaptanib
Sponsored by
L.V. Prasad Eye Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myopic Choroidal Neovascular Membrane focused on measuring Pegaptanib, myopic CNVM, intravitreal anti-VEGF

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • LV Prasad Eye Institute

Arms of the Study

Arm 1

Arm Type

Active Comparator

Arm Label

Intravitreal Pegaptanib

Arm Description

Outcomes

Primary Outcome Measures

Visual Acuity
Mean change in visual acuity from baseline to 54 weeks as measured by ETDRS chart

Secondary Outcome Measures

Mean change in macular thickness on OCT from baseline to 54 weeks

Full Information

First Posted
October 8, 2010
Last Updated
September 1, 2015
Sponsor
L.V. Prasad Eye Institute
Collaborators
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT01218230
Brief Title
Intravitreal Pegaptanib in Treatment of Choroidal Neovascularisation Secondary to Pathologic Myopia
Acronym
INGECT
Official Title
A Clinical Trial to Study the Efficacy and Safety of Intravitreal Pegaptanib in Treatment of Choroidal Neovascularisation Secondary to Pathologic Myopia
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Withdrawn
Why Stopped
Funding did not come through as the product was sold to another company.
Study Start Date
December 2010 (undefined)
Primary Completion Date
July 2012 (Anticipated)
Study Completion Date
July 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
L.V. Prasad Eye Institute
Collaborators
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopic Choroidal Neovascular Membrane
Keywords
Pegaptanib, myopic CNVM, intravitreal anti-VEGF

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intravitreal Pegaptanib
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Intravitreal Pegaptanib
Other Intervention Name(s)
Macugen
Intervention Description
Intravitreal pegaptanib, 0.3 mg, every 6 weeks for 3 injections and then PRN.
Primary Outcome Measure Information:
Title
Visual Acuity
Description
Mean change in visual acuity from baseline to 54 weeks as measured by ETDRS chart
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Mean change in macular thickness on OCT from baseline to 54 weeks
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Should be willing to participate in the trial. Age less than 55 years. Best corrected visual acuity (BCVA) score of at least 5 letters (20/200), as assessed by ETDRS chart. Myopia of ≥ 6 Diopters. Fluorescein angiographic documentation of CNV. Exclusion Criteria: Ocular causes, or other ocular disorders leading to vision loss. Maculopathy not related to pathologic myopia. Pregnancy, lactation. Not willing to provide an informed consent. History of previous macular laser including PDT. Other forms of therapy including intravitreal injections. History of intraocular surgery in the past 3 months. Anticipated cataract surgery in the next 6 months. Any active infection or inflammation in the eye. Cases where good quality imaging is not possible, either due to hazy media or extremely high myopia. Patients with uncontrolled glaucoma, with IOP > 21mm Hg on 2 or more medications. Patients with subfoveal scar or significant subretinal haemorrhage occupying more than 50% of lesion size. Eyes with previous retinal detachment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raja Narayanan, MD
Organizational Affiliation
LV Prasad Eye Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
LV Prasad Eye Institute
City
Hyderabad
State/Province
AP
ZIP/Postal Code
500034
Country
India

12. IPD Sharing Statement

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Intravitreal Pegaptanib in Treatment of Choroidal Neovascularisation Secondary to Pathologic Myopia

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