NCT01218230

Brief Summary

Intravitreal pegaptanib for treatment of choroidal neovascularisation secondary to pathologic myopia

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2010

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 8, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 11, 2010

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2010

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

September 2, 2015

Status Verified

September 1, 2015

Enrollment Period

1.6 years

First QC Date

October 8, 2010

Last Update Submit

September 1, 2015

Conditions

Myopic Choroidal Neovascular Membrane

Keywords

Pegaptanib, myopic CNVM, intravitreal anti-VEGF

Outcome Measures

Primary Outcomes (1)

  • Visual Acuity

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

    12 months

Secondary Outcomes (1)

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

    12 months

Study Arms (1)

Intravitreal Pegaptanib

ACTIVE COMPARATOR
Drug: Intravitreal Pegaptanib

Interventions

Intravitreal PegaptanibDRUG

Intravitreal pegaptanib, 0.3 mg, every 6 weeks for 3 injections and then PRN.

Also known as: Macugen
Intravitreal Pegaptanib

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

LV Prasad Eye Institute

Hyderabad, Andhra Pradesh, 500034, India

Location

MeSH Terms

Interventions

pegaptanib

Study Officials

  • Raja Narayanan, MD

    LV Prasad Eye Institute

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Clinical Research

Study Record Dates

First Submitted

October 8, 2010

First Posted

October 11, 2010

Study Start

December 1, 2010

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

September 2, 2015

Record last verified: 2015-09

Locations

IN(1)