Study for Recalcitrant Age Related Macular Degeneration (TURF)

This study has been completed.
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
David M. Brown, M.D., Greater Houston Retina Research
ClinicalTrials.gov Identifier:
NCT01543568
First received: February 27, 2012
Last updated: November 3, 2016
Last verified: November 2016
Results First Received: February 5, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Age Related Macular Degeneration
Intervention: Drug: aflibercept 2.0 mg

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients were recruited from March 2012 to September 2012. 50 subjects from 1 site of the United States from a medical clinic. Each subject was was over 50 years of age, diagnosed with choroidal neovascularization secondary to AMD, and had a history of treatment with 0.5 mg ranibizumab followed by 2.0 mg ranibizumab for AMD.

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
2.0 mg Intravitreal Aflibercept

open label, Subjects seen monthly & given mandatory 2.0 mg aflibercept at baseline, months 1, 2 and 4. Pro re nata (PRN) retreatment at months 3 and 5 was performed upon evidence of disease on spectral domain-optical coherence tomography (SD-OCT)

aflibercept 2.0 mg: Intravitreal aflibercept injection 2.0 mg


Participant Flow:   Overall Study
    2.0 mg Intravitreal Aflibercept
STARTED   46 
COMPLETED   45 
NOT COMPLETED   1 



  Baseline Characteristics
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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
2.0 mg Intravitreal Aflibercept

open label, Subjects seen monthly & given mandatory 2.0 mg aflibercept at baseline, months 1, 2 and 4. Pro re nata (PRN) retreatment at months 3 and 5 was performed upon evidence of disease on spectral domain-optical coherence tomography (SD-OCT)

aflibercept 2.0 mg: Intravitreal aflibercept injection 2.0 mg


Baseline Measures
   2.0 mg Intravitreal Aflibercept 
Overall Participants Analyzed 
[Units: Participants]
 46 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      5  10.9% 
>=65 years      41  89.1% 
Age 
[Units: Years]
Mean (Full Range)
 77.8 
 (55 to 95) 
Gender 
[Units: Participants]
Count of Participants
 
Female      24  52.2% 
Male      22  47.8% 
Region of Enrollment 
[Units: Participants]
 
United States   46 


  Outcome Measures
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1.  Primary:   The Number of Patients With no Fluid on OCT   [ Time Frame: 6 months ]

2.  Secondary:   Mean Change in OCT Central Foveal Thickness   [ Time Frame: 6 Months ]

3.  Secondary:   Average Time to Resolution of Intraretinal Cysts and Sub Retinal Fluid on OCT   [ Time Frame: 6 months ]

4.  Secondary:   The Percentage of Patients Who Lose > 15 Letters Visual Acuity   [ Time Frame: 6 Months ]

5.  Secondary:   Mean Change in Visual Acuity (BCVA)   [ Time Frame: 6 Months ]

6.  Secondary:   Quantitative Change in Area (μ) From Baseline in Choroidal Neovascular Lesion Characteristics/Size as Measured by FA/Fundus Photos   [ Time Frame: 6 Months ]

7.  Secondary:   Mean Number of 0.2 mg Aflibercept Injections Administered   [ Time Frame: at 6 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: David Brown, MD
Organization: Retina Consultants of Houston
phone: 713-524-3434
e-mail: dmbmd@houstonretina.com


Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: David M. Brown, M.D., Greater Houston Retina Research
ClinicalTrials.gov Identifier: NCT01543568     History of Changes
Other Study ID Numbers: TURF-01
Study First Received: February 27, 2012
Results First Received: February 5, 2016
Last Updated: November 3, 2016