Ranibizumab for the Inhibition of Neovascularization in the Cornea Following Corneal Transplant Surgery
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00769145 |
Recruitment Status :
Completed
First Posted : October 8, 2008
Last Update Posted : July 11, 2017
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Condition or disease | Intervention/treatment | Phase |
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Corneal Neovascularization | Drug: Ranibizumab | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 5 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Ranibizumab for the Inhibition of Neovascularization in the Cornea Following Corneal Transplant Surgery |
Study Start Date : | October 2008 |
Actual Primary Completion Date : | August 2011 |
Actual Study Completion Date : | March 2012 |

Arm | Intervention/treatment |
---|---|
Experimental: Ranibizumab
Patients to receive two injections of 0.5 mg ranibizumab subconjunctivally
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Drug: Ranibizumab
0.5mg subconjunctival dose of ranibizumab 3 days prior to corneal transplantation and at the time of corneal transplantation (total 2 injections).
Other Name: Lucentis |
- 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 ]
- 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 ]

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Ages Eligible for Study: | 18 Years to 110 Years (Adult, Older Adult) |
Sexes Eligible for Study: | 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:
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00769145
United States, Florida | |
Bascom Palmer Eye Institute | |
Miami, Florida, United States, 33136 |
Principal Investigator: | Sonia Yoo, MD | Bascom Palmer Eye Institute |
Responsible Party: | Sonia Yoo, Professor, University of Miami |
ClinicalTrials.gov Identifier: | NCT00769145 |
Other Study ID Numbers: |
20071015 |
First Posted: | October 8, 2008 Key Record Dates |
Last Update Posted: | July 11, 2017 |
Last Verified: | July 2017 |
Corneal neovascularization Ranibizumab Corneal transplantation |
Corneal Neovascularization Neovascularization, Pathologic Metaplasia Pathologic Processes Corneal Diseases Eye Diseases Ranibizumab |
Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors Antineoplastic Agents |