Completed
Conjunctival Autografting Alone or Combined With Subconjunctival Bevacizumab for Primary Pterygium Treatment.
What is being tested
Autoconjunctival grafting
+ Subconjuntival bevacizumab injection
+ Autoconjunctival grafting
ProcedureDrug
Who is being recruted
Conjunctival Diseases
+ Eye Diseases
+ Pterygium
From 18 to 70 Years
+5 Eligibility Criteria
How is the trial designed
Phase 1
Interventional
Study Start: March 2010
Summary
Principal SponsorInstituto de Oftalmología Fundación Conde de Valenciana
Last updated: December 6, 2013
Sourced from a government-validated database.Claim as a partner
Study start date: March 1, 2010
Actual date on which the first participant was enrolled.The aim of this study was to investigate the efficacy and safety of subconjunctival bevacizumab application as an adjuvant therapy for primary pterygium.
Principal SponsorInstituto de Oftalmología Fundación Conde de Valenciana
Last updated: December 6, 2013
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
49 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 18 to 70 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Conjunctival DiseasesEye DiseasesPterygium
Criteria
1 inclusion criteria required to participate
Patients with primary pterygium
4 exclusion criteria prevent from participating
Patients with diabetes mellitus
collagenopathies
pregnant or lactating patients
previous ocular surgeries
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
3 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalAutoconjunctival grafting and one subconjuntival bevacizumab injection (2.5mg/0.1ml) was applied after surgery
Group II
ExperimentalAutoconjunctival grafting and subconjuntival bevacizumab injection (2.5mg/0.1ml) was applied after surgery, with another injection 15 days after surgery
Group III
Active ComparatorAutoconjunctival grafting without subconjuntival bevacizumab injection
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
CompletedOne Study Center