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Study for Recalcitrant Age Related Macular Degeneration (TURF)

Primary Purpose

Age Related Macular Degeneration

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
aflibercept 2.0 mg
Sponsored by
David M. Brown, M.D.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Age Related Macular Degeneration focused on measuring Age related Macular Degeneration, Recalcitrant Age Related Macular Degeneration

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Ability to provide written informed consent and comply with study assessments for the full duration of the study
  • Age > 50 years
  • Choroidal neovascularization secondary to AMD
  • History of treatment with 0.5mg ranibizumab followed by 2.0mg ranibizumab for AMD
  • Best corrected visual acuity in the study eye between 20/20 to 20/400 using an ETDRS chart

Exclusion Criteria:

  • Pregnancy (positive pregnancy test) or lactation
  • Premenopausal women not using adequate contraception. The following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an IUD, or contraceptive hormone implant or patch.
  • Participation in another simultaneous medical investigation or trial
  • Prior treatment with anti-VEGF therapy in the study eye within 28 days of baseline
  • Prior treatment with PDT within the past 3 months or more than 4 prior PDT treatments.
  • Presence of significant subfoveal fibrosis or atrophy.
  • Prior treatment with intravitreal aflibercept injection
  • Prior treatment with triamcinolone in the study eye within 6 months of BSL.
  • Prior treatment with dexamethasone in the study eye within 30 days prior to BSL
  • Intraocular surgery (including cataract surgery) in the study eye within 2 months preceding Baseline
  • History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD in the study eye
  • Active intraocular inflammation (grade trace or above) in the study eye
  • Current vitreous hemorrhage in the study eye
  • History of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the study eye
  • Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye
  • Uncontrolled glaucoma in the study eye (defined as IOP ≥ 30 mmHg despite treatment with anti-glaucoma medication)
  • History of cerebral vascular accident, myocardial infarction, transient ischemic attacks within 3 months of study enrollment.
  • History of allergy to fluorescein, ICG or iodine, not amenable to treatment
  • History of retinal pigment epithelial tear or rip

Sites / Locations

  • Retina Consultants of Houston

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

2.0 mg intravitreal Aflibercept

Arm 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)

Outcomes

Primary Outcome Measures

The Number of Patients With no Fluid on OCT

Secondary Outcome Measures

Mean Change in OCT Central Foveal Thickness
Average Time to Resolution of Intraretinal Cysts and Sub Retinal Fluid on OCT
The Percentage of Patients Who Lose > 15 Letters Visual Acuity
Mean Change in Visual Acuity (BCVA)
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.
Quantitative Change in Area (μ) From Baseline in Choroidal Neovascular Lesion Characteristics/Size as Measured by FA/Fundus Photos
Mean Number of 0.2 mg Aflibercept Injections Administered

Full Information

First Posted
February 27, 2012
Last Updated
November 3, 2016
Sponsor
David M. Brown, M.D.
Collaborators
Regeneron Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01543568
Brief Title
Study for Recalcitrant Age Related Macular Degeneration
Acronym
TURF
Official Title
AflibercepT for Subjects Who Are Incomplete Responders to mUltiple Intravitreal Injections of Ranibizumab, Anti-VegF (The TURF Study)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
David M. Brown, M.D.
Collaborators
Regeneron Pharmaceuticals

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
50 Patients with recalcitrant exudative age-related macular degeneration with a history of retinal or subretinal fluid after multiple intravitreal injections with ranibizumab 0.5mg and subsequently treated with ranibizumab 2.0mg, who are incomplete responders to 2.0mg of ranibizumab.
Detailed Description
The rationale for the TURF trial is based on the greater binding affinity of VEGF Trap-eye, which theoretically may prove to be more effective for recalcitrant wet AMD and therefore may demonstrate a positive impact on visual acuity and the foveal anatomy of subjects who have a history of a less than optimal anatomical and visual response to multiple intravitreal injections of 2.0mg (super-dose) ranibizumab. Based on the anatomical data from the VIEW1 and VIEW2 trials, approximately 70% of VEGF-Trap eye patients had no evidence of fluid on OCT compared to approximately 55% of ranibizumab patients. One potential interpretation of this clinical data is that the increased binding affinity and longer half-life of VEGF-Trap eye result in the resolution of more fluid for a longer duration of effect. Patients to be enrolled in this study have a history of requiring monthly dosing of ranibizumab 2.0mg to achieve maximum resolution of fluid on OCT and increased visual acuity. These patients initially showed minimal fluid resolution visual acuity gains while treated with Lucentis (0.5mg ranibizumab) and were subsequently treated with 2.0mg monthly. It is expected that treating these same patients with 2.0mg EYLEA™ (aflibercept injection for eye) will maintain the fluid resolution on OCT and visual acuity gains previously requiring a super-dose of ranibizumab.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age Related Macular Degeneration
Keywords
Age related Macular Degeneration, Recalcitrant Age Related Macular Degeneration

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
2.0 mg intravitreal Aflibercept
Arm Type
Other
Arm 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)
Intervention Type
Drug
Intervention Name(s)
aflibercept 2.0 mg
Other Intervention Name(s)
Veg F Trap
Intervention Description
Intravitreal aflibercept injection 2.0 mg
Primary Outcome Measure Information:
Title
The Number of Patients With no Fluid on OCT
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Mean Change in OCT Central Foveal Thickness
Time Frame
6 Months
Title
Average Time to Resolution of Intraretinal Cysts and Sub Retinal Fluid on OCT
Time Frame
6 months
Title
The Percentage of Patients Who Lose > 15 Letters Visual Acuity
Time Frame
6 Months
Title
Mean Change in Visual Acuity (BCVA)
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
Title
Quantitative Change in Area (μ) From Baseline in Choroidal Neovascular Lesion Characteristics/Size as Measured by FA/Fundus Photos
Time Frame
6 Months
Title
Mean Number of 0.2 mg Aflibercept Injections Administered
Time Frame
at 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Ability to provide written informed consent and comply with study assessments for the full duration of the study Age > 50 years Choroidal neovascularization secondary to AMD History of treatment with 0.5mg ranibizumab followed by 2.0mg ranibizumab for AMD Best corrected visual acuity in the study eye between 20/20 to 20/400 using an ETDRS chart Exclusion Criteria: Pregnancy (positive pregnancy test) or lactation Premenopausal women not using adequate contraception. The following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an IUD, or contraceptive hormone implant or patch. Participation in another simultaneous medical investigation or trial Prior treatment with anti-VEGF therapy in the study eye within 28 days of baseline Prior treatment with PDT within the past 3 months or more than 4 prior PDT treatments. Presence of significant subfoveal fibrosis or atrophy. Prior treatment with intravitreal aflibercept injection Prior treatment with triamcinolone in the study eye within 6 months of BSL. Prior treatment with dexamethasone in the study eye within 30 days prior to BSL Intraocular surgery (including cataract surgery) in the study eye within 2 months preceding Baseline History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD in the study eye Active intraocular inflammation (grade trace or above) in the study eye Current vitreous hemorrhage in the study eye History of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the study eye Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye Uncontrolled glaucoma in the study eye (defined as IOP ≥ 30 mmHg despite treatment with anti-glaucoma medication) History of cerebral vascular accident, myocardial infarction, transient ischemic attacks within 3 months of study enrollment. History of allergy to fluorescein, ICG or iodine, not amenable to treatment History of retinal pigment epithelial tear or rip
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David M Brown, MD
Organizational Affiliation
Director Greater Houston Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Retina Consultants of Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22354219
Citation
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Citation
Ohr M, Kaiser PK. Intravitreal aflibercept injection for neovascular (wet) age-related macular degeneration. Expert Opin Pharmacother. 2012 Mar;13(4):585-91. doi: 10.1517/14656566.2012.658368. Epub 2012 Feb 3.
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Citation
Gragoudas ES, Adamis AP, Cunningham ET Jr, Feinsod M, Guyer DR; VEGF Inhibition Study in Ocular Neovascularization Clinical Trial Group. Pegaptanib for neovascular age-related macular degeneration. N Engl J Med. 2004 Dec 30;351(27):2805-16. doi: 10.1056/NEJMoa042760.
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Citation
CATT Research Group; Martin DF, Maguire MG, Ying GS, Grunwald JE, Fine SL, Jaffe GJ. Ranibizumab and bevacizumab for neovascular age-related macular degeneration. N Engl J Med. 2011 May 19;364(20):1897-908. doi: 10.1056/NEJMoa1102673. Epub 2011 Apr 28.
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17021318
Citation
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Citation
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Citation
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Citation
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Results Reference
derived

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Study for Recalcitrant Age Related Macular Degeneration

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