NCT01744756

Brief Summary

A study to research whether subconjunctival bevacizumab injection may potentially suppress neovascularization in pterygium, retarding and decreasing the size of recurrent pterygium.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Feb 2012

Shorter than P25 for phase_2

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

Study Start

First participant enrolled

February 1, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 29, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 7, 2012

Completed
Last Updated

December 7, 2012

Status Verified

December 1, 2012

Enrollment Period

5 months

First QC Date

November 29, 2012

Last Update Submit

December 6, 2012

Conditions

Recurrent Pterygium

Keywords

Subconjunctival BevacizumabRecurrent pterygium

Outcome Measures

Primary Outcomes (1)

  • Pterygium size after subconjunctival bevacizumab

    -Size of recurrent pterygium (measured in mm) after injection

    8 weeks

Secondary Outcomes (1)

  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability

    8 weeks

Study Arms (1)

Subconjunctival Bevacizumab

EXPERIMENTAL

One aplication of subconjunctival Bevacizumab 0,5 ml

Drug: Bevacizumab

Interventions

BevacizumabDRUG

One subconjunctival aplication of Bevacizumabe 0,5ml

Also known as: Avastin
Subconjunctival Bevacizumab

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Recurrent pterygium

You may not qualify if:

  • Pregnant or lactating women
  • History of myocardial infarction
  • History of stroke

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto de Olhos de Goiania

Goiânia, Goiás, 74110120, Brazil

Location

Related Publications (1)

  • Stival LR, Lago AM, Figueiredo MN, Bittar RH, Machado ML, Nassaralla Junior JJ. Efficacy and safety of subconjunctival bevacizumab for recurrent pterygium. Arq Bras Oftalmol. 2014 Jan-Feb;77(1):4-7. doi: 10.5935/0004-2749.20140003.

    PMID: 25076364DERIVED

MeSH Terms

Conditions

Pterygium

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Conjunctival DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Larissa S Stival, MD

    Instituto de Olhos de Goiania

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 29, 2012

First Posted

December 7, 2012

Study Start

February 1, 2012

Primary Completion

July 1, 2012

Study Completion

September 1, 2012

Last Updated

December 7, 2012

Record last verified: 2012-12

Locations

BR(1)