Intravitreal Ranibizumab in Exudative Age-related Macular Degeneration With Posterior Vitreomacular Adhesion

NCT01291121 | Completed DMC

• 1 other identifier: 4-2010-0623
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective is to determine the efficacy of intravitreal administration of Ranibizumab combined with intravitreous injection of expansile gas and induction of posterior vitreous detachment on best-corrected visual acuity and ocular coherence tomography (OCT) macular thickness in subjects with neovascular age-related macular degeneration (AMD) with posterior vitreomacular adhesion (VMA). Secondary objectives are to assess the safety and tolerability of the intravitreal administration of Ranibizumab combined with intravitreous injection of expansile gas.

Conditions

Neovascular Age-related Macular Degeneration

Keywords

Age related macular degeneration; Intravitreal ranibizumab; Intravitreal expansile gas injection

Outcome Measures

Primary Outcomes (1)

• Changes from baseline in visual acuity and central macular thickness at 12 months

  Efficacy of intravitreal administration of Ranibizumab combined with intravitreous injection of expansile gas and induction of posterior vitreous detachment on best-corrected visual acuity and ocular coherence tomography (OCT) macular thickness in subjects with exudative age-related macular degeneration (AMD) with posterior vitreomacular adhesion (VMA). Visual acuity measurement: logMAR visual acuity with early treatment of diabetic retinopathy study (ETDRS) chart, Macular thickness measurement: OCT

  12 months

Secondary Outcomes (2)

• Number of participants with nonocular complications

  12 months

• Number of participants with ocular complications

  12 months

Study Arms (1)

group 1

ACTIVE COMPARATOR

Intravitreal ranibizumab 0.5mg only group

Procedure: Intravitreal expansile gas and ranibizumab injection

Interventions

Intravitreal expansile gas and ranibizumab injection PROCEDURE

Intravitreal expansile gas (0.3 cc C3F8) and 0.5mg ranibizumab at day 0 Additional 3 monthly loading injection of intravitreal ranibizumab Additional injection of ranibizumab as needed

group 1

Eligibility Criteria

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

You may qualify if:

• Age \> 50 years old
• Exudative AMD proven by fundus photograph and fluorescein angiography (FA)with VMA proven by OCT
• Ability to provide written informed consent and comply with study assessments

You may not qualify if:

• Previous anti-VEGF treatment
• More than three prior treatment with PDT
• Previous subfoveal focal laser photocoagulation in the study eye
• Laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within 1 month preceding day 0
• Subfoveal fibrosis or atrophy in the study eye
• History of vitrectomy surgery in the study eye
• Significant concurrent ocular or macular diseases in the study eye
• medical Hx such as myocardial infarction, cerebrovascular accident, ischemic cardiomyopathy, non ocular hemorrhage
• History of Ranibizumab hypersensitivity
• Presence of active periocular infection and/or endophthalmitis

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Yonsei University Health System, Severance Hospital

Seoul, 120-752, South Korea

Location

Related Publications (14)

• Klein R, Peto T, Bird A, Vannewkirk MR. The epidemiology of age-related macular degeneration. Am J Ophthalmol. 2004 Mar;137(3):486-95. doi: 10.1016/j.ajo.2003.11.069.

  PMID: 15013873 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

• Freeman WR, Falkenstein I. Avastin and new treatments for AMD: where are we? Retina. 2006 Oct;26(8):853-8. doi: 10.1097/01.iae.0000244722.35073.7c. No abstract available.

  PMID: 17031283 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

• Lux A, Llacer H, Heussen FM, Joussen AM. Non-responders to bevacizumab (Avastin) therapy of choroidal neovascular lesions. Br J Ophthalmol. 2007 Oct;91(10):1318-22. doi: 10.1136/bjo.2006.113902. Epub 2007 May 30.

  PMID: 17537784 BACKGROUND

• Brantley MA Jr, Edelstein SL, King JM, Plotzke MR, Apte RS, Kymes SM, Shiels A. Association of complement factor H and LOC387715 genotypes with response of exudative age-related macular degeneration to photodynamic therapy. Eye (Lond). 2009 Mar;23(3):626-31. doi: 10.1038/eye.2008.28. Epub 2008 Feb 22.

  PMID: 18292785 BACKGROUND

• Brantley MA Jr, Fang AM, King JM, Tewari A, Kymes SM, Shiels A. Association of complement factor H and LOC387715 genotypes with response of exudative age-related macular degeneration to intravitreal bevacizumab. Ophthalmology. 2007 Dec;114(12):2168-73. doi: 10.1016/j.ophtha.2007.09.008.

  PMID: 18054635 BACKGROUND

• Goverdhan SV, Hannan S, Newsom RB, Luff AJ, Griffiths H, Lotery AJ. An analysis of the CFH Y402H genotype in AMD patients and controls from the UK, and response to PDT treatment. Eye (Lond). 2008 Jun;22(6):849-54. doi: 10.1038/sj.eye.6702830. Epub 2007 Apr 27.

  PMID: 17464302 BACKGROUND

• Krebs I, Brannath W, Glittenberg C, Zeiler F, Sebag J, Binder S. Posterior vitreomacular adhesion: a potential risk factor for exudative age-related macular degeneration? Am J Ophthalmol. 2007 Nov;144(5):741-746. doi: 10.1016/j.ajo.2007.07.024. Epub 2007 Sep 20.

  PMID: 17884003 BACKGROUND

• Lee SJ, Lee CS, Koh HJ. Posterior vitreomacular adhesion and risk of exudative age-related macular degeneration: paired eye study. Am J Ophthalmol. 2009 Apr;147(4):621-626.e1. doi: 10.1016/j.ajo.2008.10.003. Epub 2009 Jan 20.

  PMID: 19159862 BACKGROUND

• Mojana F, Cheng L, Bartsch DU, Silva GA, Kozak I, Nigam N, Freeman WR. The role of abnormal vitreomacular adhesion in age-related macular degeneration: spectral optical coherence tomography and surgical results. Am J Ophthalmol. 2008 Aug;146(2):218-227. doi: 10.1016/j.ajo.2008.04.027. Epub 2008 Jun 6.

  PMID: 18538742 BACKGROUND

• Ondes F, Yilmaz G, Acar MA, Unlu N, Kocaoglan H, Arsan AK. Role of the vitreous in age-related macular degeneration. Jpn J Ophthalmol. 2000 Jan-Feb;44(1):91-3. doi: 10.1016/s0021-5155(99)00174-4.

  PMID: 10698032 BACKGROUND

• Quaranta-El Maftouhi M, Mauget-Faysse M. Anomalous vitreoretinal adhesions in patients with exudative age-related macular degeneration: an OCT study. Eur J Ophthalmol. 2006 Jan-Feb;16(1):134-7.

  PMID: 16496257 BACKGROUND

• Lee SJ, Koh HJ. Effects of vitreomacular adhesion on anti-vascular endothelial growth factor treatment for exudative age-related macular degeneration. Ophthalmology. 2011 Jan;118(1):101-10. doi: 10.1016/j.ophtha.2010.04.015. Epub 2010 Aug 3.

  PMID: 20678805 BACKGROUND

MeSH Terms

Conditions

Macular Degeneration

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Hyuong Jun Koh, Professor

  Department of ophthalmology, Yonsei University College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2011
• First Posted: February 8, 2011
• Study Start: February 1, 2011
• Primary Completion: February 1, 2013
• Study Completion: June 1, 2013
• Last Updated: January 26, 2015

Record last verified: 2015-01

Locations

KR (1)