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Efficacy and Safety of Sub-tenon Ranibizumab for Recurrent Pterygia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by University of New Mexico.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Linda Rose, University of New Mexico
ClinicalTrials.gov Identifier:
NCT01169909
First received: July 23, 2010
Last updated: November 9, 2011
Last verified: November 2011

July 23, 2010
November 9, 2011
August 2010
July 2012   (final data collection date for primary outcome measure)
Safety [ Time Frame: Within the first 30 days after injection ] [ Designated as safety issue: Yes ]
The following safety criteria will be monitored: subjective complaints, objective signs of inflammation, intraocular pressure, tear film and ocular surface integrity.
Same as current
Complete list of historical versions of study NCT01169909 on ClinicalTrials.gov Archive Site
Regression of pterygium [ Time Frame: Within 30 days after drug injection ] [ Designated as safety issue: No ]
Regression of the lesion will be determined by measurement if the horizontal extension of the lesion relative to the limbus, and by photographic comparison incorporating software analysis
Same as current
Not Provided
Not Provided
 
Efficacy and Safety of Sub-tenon Ranibizumab for Recurrent Pterygia
The Use of Ranibizumab to Control Pterygium Growth in Recurrences and in Non-surgical Primary Lesions.

Ranibizumab, an effective antineovascular drug, will be studied for safety and efficacy in pterygium, a neovascular disorder of the ocular surface.

Ptergyia are chronic fibrovascular lesions of the ocular surface. This study is designed to look for a signal of efficacy when the lesions are in a phase of active vascular growth. This phase is most often caught in a newly recurring pterygia post-operatively.

Patients identified with actively growing lesions, will be offered local injections directly beneath the lesions. They will be examined for any adverse side effects and regression of the lesion.

Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Pterygium
Drug: Ranibizumab
Subtenon injections of Ranibizumab 0.5mg will be given, and repeated twice with 30 day intervals between each dose. Note, after an amendment in February 2011, this dose was increased to 2mg with the same schedule.
Experimental: Ranibizumab treatment
Patients will receive a sub-tenons injection of Ranibizumab 0.5mg, to be repeated twice with 30 day intervals between each dose.
Intervention: Drug: Ranibizumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
10
July 2012
July 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

Patients with actively growing pterygia, either surgical recurrences, or non-surgical primary lesions.

Exclusion Criteria:

  • Pregnancy
  • History of CVA
  • Monocular patients
  • Minors
Both
18 Years and older
Yes
Contact: Linda Rose, MD 505-272-6120 lirose@salud.unm.edu
Contact: Arup Das, MD 505-272-6123 adas@salud.unm.edu
United States
 
NCT01169909
09-117
No
Linda Rose, University of New Mexico
University of New Mexico
Genentech, Inc.
Not Provided
University of New Mexico
November 2011

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