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

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ClinicalTrials.gov Identifier: NCT01218230
Recruitment Status : Withdrawn (Funding did not come through as the product was sold to another company.)
First Posted : October 11, 2010
Last Update Posted : September 2, 2015
Information provided by (Responsible Party):

October 8, 2010
October 11, 2010
September 2, 2015
December 2010
July 2012   (Final data collection date for primary outcome measure)
Visual Acuity [ Time Frame: 12 months ]
Mean change in visual acuity from baseline to 54 weeks as measured by ETDRS chart
Same as current
Complete list of historical versions of study NCT01218230 on ClinicalTrials.gov Archive Site
Mean change in macular thickness on OCT from baseline to 54 weeks [ Time Frame: 12 months ]
Same as current
Not Provided
Not Provided
Intravitreal Pegaptanib in Treatment of Choroidal Neovascularisation Secondary to Pathologic Myopia
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
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.
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Myopic Choroidal Neovascular Membrane
Drug: Intravitreal Pegaptanib
Intravitreal pegaptanib, 0.3 mg, every 6 weeks for 3 injections and then PRN.
Other Name: Macugen
Active Comparator: Intravitreal Pegaptanib
Intervention: Drug: Intravitreal Pegaptanib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
July 2012
July 2012   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Raja Narayanan, L.V. Prasad Eye Institute
L.V. Prasad Eye Institute
Principal Investigator: Raja Narayanan, MD LV Prasad Eye Institute
L.V. Prasad Eye Institute
September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP