This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

Safety and Efficacy of Bevacizumab in High-Risk Corneal Transplant Survival

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Reza Dana, MD, Massachusetts Eye and Ear Infirmary
ClinicalTrials.gov Identifier:
NCT01072357
First received: February 18, 2010
Last updated: May 8, 2017
Last verified: May 2017
Results First Received: March 27, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Participant, Care Provider, Investigator;   Primary Purpose: Treatment
Conditions: Corneal Neovascularization
Corneal Graft Failure
Interventions: Drug: Avastin® (bevacizumab)
Drug: 0.9% NaCl & Refresh Liquigel

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Avastin® (Bevacizumab)

Treatment will begin on Day 0, immediately upon the conclusion of the penetrating keratoplasty procedure with an injection of 0.1 milliliter (mL) (2.5 mg) bevacizumab. Starting Day 1 post-transplant surgery, subjects will begin treatment with topical bevacizumab (1% solution). Topical treatment will be self-administered 4 times a day for 4 weeks.

The study treatments are to be given in addition to standard of care treatments. Also, all patients will follow a standard post-operative follow-up visit schedule.

Avastin® (bevacizumab): One time subconjunctival injection of 0.1 mL (2.5 mg) bevacizumab followed by topical treatment with 1% solution bevacizumab four times a day for four weeks.

0.9% NaCl & Refresh Liquigel

Treatment will begin on Day 0, immediately upon the conclusion of the penetrating keratoplasty procedure with an injection of 0.1 mL 0.9% sodium chloride (NaCl). Starting Day 1 post-transplant surgery, subjects will begin treatment with topical Refresh Liquigel. Topical treatment will be self-administered 4 times a day for 4 weeks.

The study treatments (both topical and subconjunctival injection) are to be given in addition to standard of care treatments. Also, all patients will follow a standard post-operative follow-up visit schedule.

0.9% NaCl & Refresh Liquigel: One-time subconjunctival injection of 0.1mL 0.9% NaCl followed by topical treatment with Refresh Liquigel four times a day for four weeks


Participant Flow:   Overall Study
    Avastin® (Bevacizumab)   0.9% NaCl & Refresh Liquigel
STARTED   15   15 
COMPLETED   15   14 
NOT COMPLETED   0   1 
Lost to Follow-up                0                1 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Avastin® (Bevacizumab)

Treatment will begin on Day 0, immediately upon the conclusion of the penetrating keratoplasty procedure with an injection of 0.1 milliliter (mL) (2.5 mg) bevacizumab. Starting Day 1 post-transplant surgery, subjects will begin treatment with topical bevacizumab (1% solution). Topical treatment will be self-administered 4 times a day for 4 weeks.

The study treatments are to be given in addition to standard of care treatments. Also, all patients will follow a standard post-operative follow-up visit schedule.

Avastin® (bevacizumab): One time subconjunctival injection of 0.1 mL (2.5 mg) bevacizumab followed by topical treatment with 1% solution bevacizumab four times a day for four weeks.

0.9% NaCl & Refresh Liquigel

Treatment will begin on Day 0, immediately upon the conclusion of the penetrating keratoplasty procedure with an injection of 0.1 mL 0.9% sodium chloride (NaCl). Starting Day 1 post-transplant surgery, subjects will begin treatment with topical Refresh Liquigel. Topical treatment will be self-administered 4 times a day for 4 weeks.

The study treatments (both topical and subconjunctival injection) are to be given in addition to standard of care treatments. Also, all patients will follow a standard post-operative follow-up visit schedule.

0.9% NaCl & Refresh Liquigel: One-time subconjunctival injection of 0.1mL 0.9% NaCl followed by topical treatment with Refresh Liquigel four times a day for four weeks

Total Total of all reporting groups

Baseline Measures
   Avastin® (Bevacizumab)   0.9% NaCl & Refresh Liquigel   Total 
Overall Participants Analyzed 
[Units: Participants]
 15   14   29 
Age 
[Units: Years]
Mean (Standard Deviation)
 71.3  (17.0)   63.0  (13.0)   67.2  (15.5) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      8  53.3%      8  57.1%      16  55.2% 
Male      7  46.7%      6  42.9%      13  44.8% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
     
White   8   10   18 
Hispanic   2   1   3 
African American   4   3   7 
Asian   1   0   1 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With Graft Failure at Week 39 and 52   [ Time Frame: 12 months ]

2.  Secondary:   Endothelial Cell Density   [ Time Frame: 52 Weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Reza Dana
Organization: Massachusetts Eye and Ear
phone: 617-573-4431 ext 4431
e-mail: Reza_Dana@meei.harvard.edu



Responsible Party: Reza Dana, MD, Massachusetts Eye and Ear Infirmary
ClinicalTrials.gov Identifier: NCT01072357     History of Changes
Other Study ID Numbers: 09-07-062
Study First Received: February 18, 2010
Results First Received: March 27, 2017
Last Updated: May 8, 2017