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Study for Recalcitrant Age Related Macular Degeneration (TURF)

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ClinicalTrials.gov Identifier: NCT01543568
Recruitment Status : Completed
First Posted : March 5, 2012
Results First Posted : January 2, 2017
Last Update Posted : January 2, 2017
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
David M. Brown, M.D., Greater Houston Retina Research

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Age Related Macular Degeneration
Intervention Drug: aflibercept 2.0 mg
Enrollment 46
Recruitment Details 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  
Arm/Group Title 2.0 mg Intravitreal Aflibercept
Hide Arm/Group Description

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

Period Title: Overall Study
Started 46
Completed 45
Not Completed 1
Arm/Group Title 2.0 mg Intravitreal Aflibercept
Hide Arm/Group Description

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

Overall Number of Baseline Participants 46
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 46 participants
<=18 years
0
   0.0%
Between 18 and 65 years
5
  10.9%
>=65 years
41
  89.1%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 46 participants
77.8
(55 to 95)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 46 participants
Female
24
  52.2%
Male
22
  47.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 46 participants
46
1.Primary Outcome
Title The Number of Patients With no Fluid on OCT
Hide Description [Not Specified]
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 2.0 mg Intravitreal Aflibercept
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 46
Measure Type: Number
Unit of Measure: participants
10
2.Secondary Outcome
Title Mean Change in OCT Central Foveal Thickness
Hide Description [Not Specified]
Time Frame 6 Months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 2.0 mg Intravitreal Aflibercept
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 46
Mean (Full Range)
Unit of Measure: micrometers
-27.3
(-381 to 59)
3.Secondary Outcome
Title Average Time to Resolution of Intraretinal Cysts and Sub Retinal Fluid on OCT
Hide Description [Not Specified]
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 2.0 mg Intravitreal Aflibercept
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 46
Mean (Full Range)
Unit of Measure: months
4
(0 to 6)
4.Secondary Outcome
Title The Percentage of Patients Who Lose > 15 Letters Visual Acuity
Hide Description [Not Specified]
Time Frame 6 Months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 2.0 mg Intravitreal Aflibercept
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 46
Measure Type: Number
Unit of Measure: Percentage of patients
0
5.Secondary Outcome
Title Mean Change in Visual Acuity (BCVA)
Hide Description Change in Early Treatment of Diabetic Retinopathy Study Best Corrected Visual Acuity (ETDRS-BCVA) from baseline to month 6. BCVA is measured using an eye chart and is reported as the number of letters read correctly using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.
Time Frame 6 Months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 2.0 mg Intravitreal Aflibercept
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 46
Mean (Full Range)
Unit of Measure: ETDRS BCVA letters
0.2
(-10 to 13)
6.Secondary Outcome
Title Quantitative Change in Area (μ) From Baseline in Choroidal Neovascular Lesion Characteristics/Size as Measured by FA/Fundus Photos
Hide Description [Not Specified]
Time Frame 6 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Given lack of visual benefit upon switching to aflibercept (Eylea), such analyses were not performed.
Arm/Group Title 2.0 mg Intravitreal Aflibercept
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Mean Number of 0.2 mg Aflibercept Injections Administered
Hide Description [Not Specified]
Time Frame at 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 2.0 mg Intravitreal Aflibercept
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 46
Mean (Full Range)
Unit of Measure: injections
5.6
(4 to 6)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 2.0 mg Intravitreal Aflibercept
Hide Arm/Group Description

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

All-Cause Mortality
2.0 mg Intravitreal Aflibercept
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
2.0 mg Intravitreal Aflibercept
Affected / at Risk (%)
Total   9/45 (20.00%) 
Cardiac disorders   
Death  1/45 (2.22%) 
Atrial fibrillation  1/45 (2.22%) 
Infections and infestations   
Urinary Tract Infection  2/45 (4.44%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Squamous cell carcinoma  2/45 (4.44%) 
Respiratory, thoracic and mediastinal disorders   
Upper respiratory tract infection  5/45 (11.11%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
2.0 mg Intravitreal Aflibercept
Affected / at Risk (%)
Total   6/45 (13.33%) 
Eye disorders   
Cataract Progression  3/45 (6.67%) 
Geographic atrophy progression  3/45 (6.67%) 
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
Publications:
Responsible Party: David M. Brown, M.D., Greater Houston Retina Research
ClinicalTrials.gov Identifier: NCT01543568     History of Changes
Other Study ID Numbers: TURF-01
First Submitted: February 27, 2012
First Posted: March 5, 2012
Results First Submitted: February 5, 2016
Results First Posted: January 2, 2017
Last Update Posted: January 2, 2017