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CompletedNCT00769145Updated Jul 11, 2017

Ranibizumab for the Inhibition of Neovascularization in the Cornea Following Corneal Transplant Surgery

A Phase 1 interventional study of Ranibizumab in Corneal Neovascularization, sponsored by University of Miami. Completed at 1 site in United States. Open to participants aged 18 Years to 110 Years. Per ClinicalTrials.gov, last updated 2017-07-11.

Sponsored by University of Miami · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
5
Allocation
Not applicable
Ages
18 Years to 110 Years
Sex
All
01

Study summary

The primary purpose of this trial is to evaluate the safety and tolerability of ranibizumab given via subconjunctival injection in patients undergoing corneal transplantation.

Read the detailed description

As a secondary objective, this study also aims to establish the corneal and anterior chamber concentration of ranibizumab when delivered subconjunctivally at the limbus in patients undergoing corneal transplantation. The effects of ranibizumab on corneal epithelial healing will be examined following adjunctive use in corneal transplantation. Finally, clinical characteristics including recurrent corneal neovascularization will be studied.

02

Conditions studied

  • Corneal Neovascularization

Keywords

  • Corneal neovascularization
  • Ranibizumab
  • Corneal transplantation
03

In context

Corneal Neovascularization

27 studies on the registry are indexed under Corneal Neovascularization; 4 are open to participants now.

This study's enrollment of 5 is below the median of 24 across 22 interventional studies indexed under Corneal Neovascularization.

Browse Corneal Neovascularization studies →

Lead sponsor

University of Miami is the lead sponsor of 820 studies on the registry; 161 are open to participants now.

Of its 111 completed or terminated interventional studies of FDA-regulated products, 93 (84%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 110 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

Subjects will be eligible if the following criteria are met:

  • Ability to provide written informed consent and comply with study assessments for the full duration of the study
  • Age > 18 years
  • Patient related considerations
  • All patients of both genders will be considered for enrollment.
  • Disease related considerations
  • Patients meeting accepted criteria for undergoing corneal transplantation will be considered if peripheral corneal neovascularization exists in 2 or more contiguous clock hours

Exclusion criteria

Exclusion Criteria:

Subjects who meet any of the following criteria will be excluded from this study:

  • Pregnancy (positive pregnancy test)
  • Women seeking to become pregnant
  • Lactating women
  • Prior enrollment in the study
  • Prior glaucoma surgery in the region of the corneal neovascularization
  • Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
  • Participation in another simultaneous medical investigation or trial
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
5 participants (actual)

Study arms

  • Experimental
    Ranibizumab

    Patients to receive two injections of 0.5 mg ranibizumab subconjunctivally

    Drug: Ranibizumab

Interventions

  • DrugRanibizumab

    0.5mg subconjunctival dose of ranibizumab 3 days prior to corneal transplantation and at the time of corneal transplantation (total 2 injections).

    Also known as: Lucentis

06

What researchers measure

Primary outcomes

  1. The primary purpose of this trial is to evaluate the safety and tolerability of ranibizumab given via subconjunctival injection in patients undergoing corneal transplantation.

    Time frame: 2 years

Secondary outcomes

  1. This study also aims to establish the corneal and anterior chamber concentration of ranibizumab when delivered subconjunctivally. The effects of ranibizumab on corneal epithelial healing and prevention of recurrent neovascularization will be examined.

    Time frame: 2 years

07

Study locations

1 site
  • Bascom Palmer Eye Institute
    Miami, Florida 33136, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 11, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00769145
Lead sponsor
University of Miami
Collaborators
Genentech, Inc.
Responsible party
Sonia Yoo (Professor, University of Miami) — Principal investigator
First posted
Oct 8, 2008
Start date
Oct 2008
Primary completion
Aug 2011
Completion
Mar 2012
Last update
Jul 11, 2017

Study contacts

Sonia Yoo, MD
principal investigator · Bascom Palmer Eye Institute

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.

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