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Study for Recalcitrant Age Related Macular Degeneration (TURF)

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

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.

Condition or disease Intervention/treatment Phase
Age Related Macular Degeneration Drug: aflibercept 2.0 mg Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: AflibercepT for Subjects Who Are Incomplete Responders to mUltiple Intravitreal Injections of Ranibizumab, Anti-VegF (The TURF Study)
Study Start Date : February 2012
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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)
Drug: aflibercept 2.0 mg
Intravitreal aflibercept injection 2.0 mg
Other Name: Veg F Trap

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

Secondary Outcome Measures :
  1. Mean Change in OCT Central Foveal Thickness [ Time Frame: 6 Months ]
  2. Average Time to Resolution of Intraretinal Cysts and Sub Retinal Fluid on OCT [ Time Frame: 6 months ]
  3. The Percentage of Patients Who Lose > 15 Letters Visual Acuity [ Time Frame: 6 Months ]
  4. Mean Change in Visual Acuity (BCVA) [ Time Frame: 6 Months ]
    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.

  5. Quantitative Change in Area (μ) From Baseline in Choroidal Neovascular Lesion Characteristics/Size as Measured by FA/Fundus Photos [ Time Frame: 6 Months ]
  6. Mean Number of 0.2 mg Aflibercept Injections Administered [ Time Frame: at 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01543568

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United States, Texas
Retina Consultants of Houston
Houston, Texas, United States, 77030
Sponsors and Collaborators
David M. Brown, M.D.
Regeneron Pharmaceuticals
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Principal Investigator: David M Brown, MD Director Greater Houston Research

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: David M. Brown, M.D., Director of Research, Greater Houston Retina Research Identifier: NCT01543568    
Other Study ID Numbers: TURF-01
First Posted: March 5, 2012    Key Record Dates
Results First Posted: January 2, 2017
Last Update Posted: January 2, 2017
Last Verified: November 2016
Keywords provided by David M. Brown, M.D., Greater Houston Retina Research:
Age related Macular Degeneration
Recalcitrant Age Related Macular Degeneration
Additional relevant MeSH terms:
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Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases