Study for Recalcitrant Age Related Macular Degeneration (TURF)

This study is ongoing, but not recruiting participants.
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: March 4, 2014
Last verified: March 2014
  Purpose

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 Intervention Phase
Age Related Macular Degeneration
Drug: aflibercept 2.0 mg
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Greater Houston Retina Research:

Primary Outcome Measures:
  • The percentage of patients with no fluid on OCT [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean change in OCT central foveal thickness [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
  • Time to resolution of intraretinal cysts and sub retinal fluid on OCT [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • The percentage of patients who lose < 15 letters visual acuity [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
  • Mean change in visual acuity (BCVA) [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
  • Quantitative change in area (μ) from baseline in choroidal neovascular lesion characteristics/size as measured by FA/Fundus photos [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
  • Data measurement [ Time Frame: at least 12 months from 6 months completion visit ] [ Designated as safety issue: No ]
    an evaluation visit for all enrolled patients to occur no earlier than 12 months after completion of the last scheduled visit during Interventional period (6 months from Visit 1)


Enrollment: 46
Study Start Date: February 2012
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: aflibercept 2.0 mg
    Intravitreal aflibercept injection 2.0 mg
    Other Name: Veg F Trap
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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01543568

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

Publications:

Responsible Party: David M. Brown, M.D., Director of Research, Greater Houston Retina Research
ClinicalTrials.gov Identifier: NCT01543568     History of Changes
Other Study ID Numbers: TURF-01
Study First Received: February 27, 2012
Last Updated: March 4, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Greater Houston Retina Research:
Age related Macular Degeneration
Recalcitrant Age Related Macular Degeneration

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on April 17, 2014