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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by L.V. Prasad Eye Institute.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Pfizer
Information provided by:
L.V. Prasad Eye Institute
ClinicalTrials.gov Identifier:
NCT01218230
First received: October 8, 2010
Last updated: NA
Last verified: October 2010
History: No changes posted

October 8, 2010
October 8, 2010
December 2010
July 2012   (final data collection date for primary outcome measure)
Visual Acuity [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Mean change in visual acuity from baseline to 54 weeks as measured by ETDRS chart
Same as current
No Changes Posted
Mean change in macular thickness on OCT from baseline to 54 weeks [ Time Frame: 12 months ] [ Designated as safety issue: No ]
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.

Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.
 
Not yet recruiting
20
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.
Both
18 Years and older
No
Contact: Samuel Clement 91-40-30612525 ext 2525 samuel@lvpei.org
Contact: Raja Narayanan, MD 91-40-30612607 narayanan@lvpei.org
India
 
NCT01218230
LEC08205
No
Raja Narayanan, MD, LV Prasad Eye Institute
L.V. Prasad Eye Institute
Pfizer
Principal Investigator: Raja Narayanan, MD LV Prasad Eye Institute
L.V. Prasad Eye Institute
October 2010

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