Study for Recalcitrant Age Related Macular Degeneration

NCT01543568 | Completed Phase 4 Results DMC

• 1 other identifier: TURF-01
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Age Related Macular Degeneration

Keywords

Age related Macular Degeneration; Recalcitrant Age Related Macular Degeneration

Outcome Measures

Primary Outcomes (1)

• The Number of Patients With no Fluid on OCT

  6 months

Secondary Outcomes (6)

• Mean Change in OCT Central Foveal Thickness

  6 Months

• Average Time to Resolution of Intraretinal Cysts and Sub Retinal Fluid on OCT

  6 months

• The Percentage of Patients Who Lose > 15 Letters Visual Acuity

  6 Months

• Mean Change in Visual Acuity (BCVA)

  6 Months

• Quantitative Change in Area (μ) From Baseline in Choroidal Neovascular Lesion Characteristics/Size as Measured by FA/Fundus Photos

  6 Months

Study Arms (1)

2.0 mg intravitreal Aflibercept

OTHER

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

Interventions

aflibercept 2.0 mg DRUG

Intravitreal aflibercept injection 2.0 mg

Also known as: Veg F Trap

2.0 mg intravitreal Aflibercept

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• David M. Brown, M.D.: lead
• Regeneron Pharmaceuticals: collaborator

Study Sites (1)

Retina Consultants of Houston

Houston, Texas, 77030, United States

Location

Related Publications (16)

• Aflibercept (eylea) for age-related macular degeneration. Med Lett Drugs Ther. 2012 Feb 6;54(1383):9-10. No abstract available.

  PMID: 22354219 BACKGROUND

• 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.

  PMID: 22300011 BACKGROUND

• 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.

  PMID: 15625332 BACKGROUND

• 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.

  PMID: 21526923 BACKGROUND

• Rosenfeld PJ, Brown DM, Heier JS, Boyer DS, Kaiser PK, Chung CY, Kim RY; MARINA Study Group. Ranibizumab for neovascular age-related macular degeneration. N Engl J Med. 2006 Oct 5;355(14):1419-31. doi: 10.1056/NEJMoa054481.

  PMID: 17021318 BACKGROUND

• Brown DM, Kaiser PK, Michels M, Soubrane G, Heier JS, Kim RY, Sy JP, Schneider S; ANCHOR Study Group. Ranibizumab versus verteporfin for neovascular age-related macular degeneration. N Engl J Med. 2006 Oct 5;355(14):1432-44. doi: 10.1056/NEJMoa062655.

  PMID: 17021319 BACKGROUND

• Rosenfeld PJ, Moshfeghi AA, Puliafito CA. Optical coherence tomography findings after an intravitreal injection of bevacizumab (avastin) for neovascular age-related macular degeneration. Ophthalmic Surg Lasers Imaging. 2005 Jul-Aug;36(4):331-5.

  PMID: 16156152 BACKGROUND

• Avery RL, Pieramici DJ, Rabena MD, Castellarin AA, Nasir MA, Giust MJ. Intravitreal bevacizumab (Avastin) for neovascular age-related macular degeneration. Ophthalmology. 2006 Mar;113(3):363-372.e5. doi: 10.1016/j.ophtha.2005.11.019. Epub 2006 Feb 3.

  PMID: 16458968 BACKGROUND

• Fung AE, Lalwani GA, Rosenfeld PJ, Dubovy SR, Michels S, Feuer WJ, Puliafito CA, Davis JL, Flynn HW Jr, Esquiabro M. An optical coherence tomography-guided, variable dosing regimen with intravitreal ranibizumab (Lucentis) for neovascular age-related macular degeneration. Am J Ophthalmol. 2007 Apr;143(4):566-83. doi: 10.1016/j.ajo.2007.01.028.

  PMID: 17386270 BACKGROUND

• Iida T, Yannuzzi LA, Spaide RF, Borodoker N, Carvalho CA, Negrao S. Cystoid macular degeneration in chronic central serous chorioretinopathy. Retina. 2003 Feb;23(1):1-7; quiz 137-8. doi: 10.1097/00006982-200302000-00001.

  PMID: 12652224 BACKGROUND

• Imamura Y, Fujiwara T, Spaide RF. Fundus autofluorescence and visual acuity in central serous chorioretinopathy. Ophthalmology. 2011 Apr;118(4):700-5. doi: 10.1016/j.ophtha.2010.08.017. Epub 2010 Nov 5.

  PMID: 21055816 BACKGROUND

• Stewart MW, Rosenfeld PJ. Predicted biological activity of intravitreal VEGF Trap. Br J Ophthalmol. 2008 May;92(5):667-8. doi: 10.1136/bjo.2007.134874. Epub 2008 Mar 20.

  PMID: 18356264 BACKGROUND

• Kaiser PK. Vascular endothelial growth factor Trap-Eye for diabetic macular oedema. Br J Ophthalmol. 2009 Feb;93(2):135-6. doi: 10.1136/bjo.2008.144071. No abstract available.

  PMID: 19174397 BACKGROUND

• Holash J, Davis S, Papadopoulos N, Croll SD, Ho L, Russell M, Boland P, Leidich R, Hylton D, Burova E, Ioffe E, Huang T, Radziejewski C, Bailey K, Fandl JP, Daly T, Wiegand SJ, Yancopoulos GD, Rudge JS. VEGF-Trap: a VEGF blocker with potent antitumor effects. Proc Natl Acad Sci U S A. 2002 Aug 20;99(17):11393-8. doi: 10.1073/pnas.172398299. Epub 2002 Aug 12.

  PMID: 12177445 BACKGROUND

• Eyetech Study Group. Preclinical and phase 1A clinical evaluation of an anti-VEGF pegylated aptamer (EYE001) for the treatment of exudative age-related macular degeneration. Retina. 2002 Apr;22(2):143-52. doi: 10.1097/00006982-200204000-00002.

  PMID: 11927845 BACKGROUND

• Wykoff CC, Brown DM, Maldonado ME, Croft DE. Aflibercept treatment for patients with exudative age-related macular degeneration who were incomplete responders to multiple ranibizumab injections (TURF trial). Br J Ophthalmol. 2014 Jul;98(7):951-5. doi: 10.1136/bjophthalmol-2013-304736. Epub 2014 Feb 11.

  PMID: 24518078 DERIVED

MeSH Terms

Conditions

Macular Degeneration

Interventions

aflibercept

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Results Point of Contact

• Title: David Brown, MD
• Organization: Retina Consultants of Houston

dmbmd@houstonretina.com

713-524-3434

Study Officials

• David M Brown, MD

  Director Greater Houston Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Research

Study Record Dates

• First Submitted: February 27, 2012
• First Posted: March 5, 2012
• Study Start: February 1, 2012
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: January 2, 2017
• Results First Posted: January 2, 2017

Record last verified: 2016-11

Locations

US (1)