NCT01169909

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Aug 2010

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

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

July 23, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 26, 2010

Completed
6 days until next milestone

Study Start

First participant enrolled

August 1, 2010

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

May 17, 2016

Status Verified

May 1, 2016

Enrollment Period

3.9 years

First QC Date

July 23, 2010

Last Update Submit

May 13, 2016

Conditions

Pterygium

Keywords

Pterygium

Outcome Measures

Primary Outcomes (1)

  • Safety

    The following safety criteria will be monitored: subjective complaints, objective signs of inflammation, intraocular pressure, tear film and ocular surface integrity.

    Within the first 30 days after injection

Secondary Outcomes (1)

  • Regression of pterygium

    Within 30 days after drug injection

Study Arms (1)

Ranibizumab treatment

EXPERIMENTAL

Patients will receive a sub-tenons injection of Ranibizumab 0.5mg, to be repeated twice with 30 day intervals between each dose.

Drug: Ranibizumab

Interventions

RanibizumabDRUG

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.

Ranibizumab treatment

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • Pregnancy
  • History of CVA
  • Monocular patients
  • Minors

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of New Mexico Health Science Center

Albuquerque, New Mexico, 87106, United States

Location

MeSH Terms

Conditions

Pterygium

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Conjunctival DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 23, 2010

First Posted

July 26, 2010

Study Start

August 1, 2010

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

May 17, 2016

Record last verified: 2016-05

Locations

US(1)