Efficacy and Safety of Sub-tenon Ranibizumab for Recurrent Pterygia
This study is currently recruiting participants.
Verified November 2011 by University of New Mexico
Sponsor:
University of New Mexico
Collaborator:
Genentech
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
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Purpose
Ranibizumab, an effective antineovascular drug, will be studied for safety and efficacy in pterygium, a neovascular disorder of the ocular surface.
| Condition | Intervention | Phase |
|---|---|---|
|
Pterygium |
Drug: Ranibizumab |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | The Use of Ranibizumab to Control Pterygium Growth in Recurrences and in Non-surgical Primary Lesions. |
Resource links provided by NLM:
Further study details as provided by University of New Mexico:
Primary Outcome Measures:
- 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.
Secondary Outcome Measures:
- 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
| Estimated Enrollment: | 10 |
| Study Start Date: | August 2010 |
| Estimated Study Completion Date: | July 2012 |
| Estimated Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
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.
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
Patients with actively growing pterygia, either surgical recurrences, or non-surgical primary lesions.
Exclusion Criteria:
- Pregnancy
- History of CVA
- Monocular patients
- Minors
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01169909
Contacts
| Contact: Linda Rose, MD | 505-272-6120 | lirose@salud.unm.edu |
| Contact: Arup Das, MD | 505-272-6123 | adas@salud.unm.edu |
Locations
| United States, New Mexico | |
| University of New Mexico Health Science Center | Recruiting |
| Albuquerque, New Mexico, United States, 87106 | |
| Principal Investigator: Linda Rose, MD PhD | |
Sponsors and Collaborators
University of New Mexico
Genentech
More Information
No publications provided
| Responsible Party: | Linda Rose, Principal Investigator, University of New Mexico |
| ClinicalTrials.gov Identifier: | NCT01169909 History of Changes |
| Other Study ID Numbers: | 09-117 |
| Study First Received: | July 23, 2010 |
| Last Updated: | November 9, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by University of New Mexico:
|
Pterygium |
Additional relevant MeSH terms:
|
Pterygium Conjunctival Diseases Eye Diseases |
ClinicalTrials.gov processed this record on October 17, 2012
