Efficacy and Safety Study of Avastin to Treat Neovascularisation of the Cornea

NCT01501760 | Completed Phase 3 DMC

• 1 other identifier: I07034
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 5

Brief Summary

Corneal newvessels may arise from a fan of pathologies, inducing long-standing corneal opacification requiring keratoplasty. These last years, VEGF inhibitors have been designed to reduce newascularization induced by gastric cancer or age-related macular degeneration. A few reports have been published showing the interest of VEGF inhibitors to treat corneal newvessels, but no randomized study has been achieved to date. This study is designed to assess the efficacy of Bevacizumab, a VEGF inhibitor monoclonal antibody, to reduce the surface of corneal newvessels in when compared to placebo

Conditions

Corneal Newvessels

Outcome Measures

Primary Outcomes (1)

• Neovascularisation reduction at 3 months

  Assessement using color photographs and a picture-analyser software that will calculate the percentage of corneal surface occupied by the newvessels at 3 months. A reduction of 30% is target.

  at 3 months

Secondary Outcomes (2)

• Local and general toxicity of bevacizumab

  at 1 months, 2 month, 3 month, 6 month

• Efficacy at 6 months

  at 6 month

Study Arms (2)

bevacizumab

EXPERIMENTAL

Three subconjunctival injections of 0.5 ml of bevacizumab at inclusion, 1 month, 2 month.

Drug: bevacizumab

Placebo

PLACEBO COMPARATOR

Three subconjunctival injections of 0.5 ml of Nacl at inclusion, 1 month, 2 month.

Drug: NaCl

Interventions

bevacizumab DRUG

Three subconjunctival injections of 0.5 ml of bevacizumab at: inclusion, 1 month, 2 month

bevacizumab

NaCl DRUG

Three subconjunctival injections 0.5 ml placebo (Balanced salt) solution at inclusion, 1 month, 2month

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with corneal neovascularization whatever the origin
• Patient who has been properly informed and signed consent
• Patient aged over 18
• Patient affiliated with a health insurance plan or benefit of such a regime

You may not qualify if:

• Patients who received local or general treatment of concomitant prostaglandin derivatives
• Patients with current infection of the cornea or other tissue / organ
• Women of childbearing age without contraception
• Pregnancy and Lactation
• Patient participating in another study
• Patient with contact lenses
• Patients with uncontrolled hypertension
• Patient with a history of stroke, myocardial infarction, angina pectoris, thrombophlebitis, Raynaud's phenomenon.
• Patients hypersensitive to the active substance or any excipients
• Patients hypersensitive to products of Chinese hamster ovary cells or other recombinant human or humanized antibodies.
• Patients with active bacterial eye infections, fungal, parasitic or viral infection (with the exception of herpes)

Sponsors & Collaborators

• University Hospital, Limoges: lead

Study Sites (5)

Service d'Ophtalmologie

Limoges, 87042, France

Location

CHU Poitiers-Ophtalmologie

Poitiers, 86021, France

Location

CHU St Etienne

Saint-Etienne, France

Location

CHU Strasbourg- Service Ophtalmlogie

Strasbourg, 67000, France

Location

CHU de Toulouse, Service d'Ophtalmologie

Toulouse, 31059, France

Location

MeSH Terms

Interventions

Bevacizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 26, 2011
• First Posted: December 29, 2011
• Study Start: May 13, 2012
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: October 24, 2019

Record last verified: 2018-10

Locations

FR (5)