Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT01218230
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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Recruitment Status : Withdrawn (Funding did not come through as the product was sold to another company.)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
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Raja Narayanan, L.V. Prasad Eye Institute

Tracking Information
First Submitted Date  ICMJE October 8, 2010
First Posted Date  ICMJE October 11, 2010
Last Update Posted Date September 2, 2015
Study Start Date  ICMJE December 2010
Estimated Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 8, 2010)
Visual Acuity [ Time Frame: 12 months ]
Mean change in visual acuity from baseline to 54 weeks as measured by ETDRS chart
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 8, 2010)
Mean change in macular thickness on OCT from baseline to 54 weeks [ Time Frame: 12 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intravitreal Pegaptanib in Treatment of Choroidal Neovascularisation Secondary to Pathologic Myopia
Official Title  ICMJE A Clinical Trial to Study the Efficacy and Safety of Intravitreal Pegaptanib in Treatment of Choroidal Neovascularisation Secondary to Pathologic Myopia
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Myopic Choroidal Neovascular Membrane
Intervention  ICMJE Drug: Intravitreal Pegaptanib
Intravitreal pegaptanib, 0.3 mg, every 6 weeks for 3 injections and then PRN.
Other Name: Macugen
Study Arms  ICMJE Active Comparator: Intravitreal Pegaptanib
Intervention: Drug: Intravitreal Pegaptanib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: September 1, 2015)
0
Original Estimated Enrollment  ICMJE
 (submitted: October 8, 2010)
20
Estimated Study Completion Date  ICMJE July 2012
Estimated Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01218230
Other Study ID Numbers  ICMJE LEC08205
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Raja Narayanan, L.V. Prasad Eye Institute
Study Sponsor  ICMJE L.V. Prasad Eye Institute
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator: Raja Narayanan, MD LV Prasad Eye Institute
PRS Account L.V. Prasad Eye Institute
Verification Date September 2015

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