Intravitreal Gas for Vitreomacular Adhesion

NCT02001701 | Withdrawn

• 1 other identifier: NCRVA - 2013 - RELEASE
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Vitreomacular adhesion causes symptoms of blurry vision, distortion, and double vision. It is due to an abnormal separation of the vitreous gel from the surface of the retina and macula. The current, gold-standard treatment for this condition involves surgery performed in the operating room that involves risk such as bleeding, infection, cataract, and retinal detachment. It has been previously shown that a less invasive intravitreal injection of a gas bubble performed in the office may also treat vitreomacular adhesion with less risk than surgery. The purpose of this study is to determine the effect of an office-based injection of an intravitreal gas bubble as a treatment for symptomatic vitreomacular adhesion.

Conditions

Vitreomacular Adhesion

Keywords

vitreomacular adhesion; vitreomacular traction; macular hole; epiretinal membrane; intravitreal gas; sulfahexafluoride gas; perfluoropropane gas; ocriplasmin; vitrectomy

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with resolution of vitreomacular adhesion at Day 28

  Day 28

Secondary Outcomes (6)

• Change in Visual Acuity

  Day 14

• Change in Visual Acuity

  Day 28

• Change in Visual Acuity

  Day 90

• Time to resolution of vitreomacular adhesion

  Day 90

• Proportion of patients requiring vitrectomy surgery

  Day 90

Study Arms (1)

Intravitreal Gas

EXPERIMENTAL

Intravitreal injection of sulfahexafluoride gas

Procedure: Intravitreal Injection of sulfahexafluoride gas

Interventions

Intravitreal Injection of sulfahexafluoride gas PROCEDURE

After the appropriate sterile and anesthetic preparation of the surgical field, the investigator will administer a single intravitreal injection of 0.3 to 0.5 cc of sulfahexafluoride gas in the study eye. An anterior chamber paracentesis may be performed if necessary. Following the procedure, the optic nerve will be monitored for perfusion.

Intravitreal Gas

Eligibility Criteria

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

You may qualify if:

• Age 18 or older
• Able to provide written informed consent
• Patients with Symptomatic Vitreomacular Adhesion (sVMA) as defined by Clinical and SD-OCT findings:
• Clinical Findings:
• Symptoms: blurred vision, double vision, metamorphopsia, micropsia
• Snellen Visual Acuity: \< 20/25 in study eye
• SD-OCT (Cirrus, Car Zeiss Meditec, Dublin, CA) Findings:
• Visible vitreous attachment within a 1,500 um radius of the foveal center causing antero-posterior vitreofoveal traction with associated microstructural retinal changes
• Observation period of 1 month prior to intervention allowing for spontaneous resolution

You may not qualify if:

• Figure 1 (Images "A", "B", "C", "D", "F", "H", "I")
• Any Macular Hole
• Epiretinal Membrane
• History of Diabetic Retinopathy (non-proliferative, proliferative, and/or diabetic macular edema)
• Macular Degeneration
• Retinal vascular occlusion
• Aphakia
• High myopia (\> -8 diopters)
• Uncontrolled glaucoma
• Vitreous Opacification
• Retinal tear or retinal detachment
• Vitrectomy surgery
• Macular laser
• Figure 1: Refer to the following article:
• Stalmans P, Duker JS, Kaiser PK, et al. OCT-Based Interpretation of the Vitreomacular Interface and Indications for Pharmacologic Vitreolysis. Retina; 2013: Epub ahead of print

Sponsors & Collaborators

• Northern California Retina Vitreous Associates: lead

Study Sites (1)

Northern California Retina Vitreous Associates

Mountain View, California, 94040, United States

Location

Related Publications (13)

• Stalmans P, Duker JS, Kaiser PK, Heier JS, Dugel PU, Gandorfer A, Sebag J, Haller JA. Oct-based interpretation of the vitreomacular interface and indications for pharmacologic vitreolysis. Retina. 2013 Nov-Dec;33(10):2003-11. doi: 10.1097/IAE.0b013e3182993ef8.

  PMID: 23881226 BACKGROUND

• Chang LK, Fine HF, Spaide RF, Koizumi H, Grossniklaus HE. Ultrastructural correlation of spectral-domain optical coherence tomographic findings in vitreomacular traction syndrome. Am J Ophthalmol. 2008 Jul;146(1):121-7. doi: 10.1016/j.ajo.2008.03.001. Epub 2008 Apr 25.

  PMID: 18439563 BACKGROUND

• Witkin AJ, Patron ME, Castro LC, Reichel E, Rogers AH, Baumal CR, Duker JS. Anatomic and visual outcomes of vitrectomy for vitreomacular traction syndrome. Ophthalmic Surg Lasers Imaging. 2010 Jul-Aug;41(4):425-31. doi: 10.3928/15428877-20100525-07. Epub 2010 May 28.

  PMID: 20608611 BACKGROUND

• Recchia FM, Scott IU, Brown GC, Brown MM, Ho AC, Ip MS. Small-gauge pars plana vitrectomy: a report by the American Academy of Ophthalmology. Ophthalmology. 2010 Sep;117(9):1851-7. doi: 10.1016/j.ophtha.2010.06.014.

  PMID: 20816248 BACKGROUND

• Stalmans P, Benz MS, Gandorfer A, Kampik A, Girach A, Pakola S, Haller JA; MIVI-TRUST Study Group. Enzymatic vitreolysis with ocriplasmin for vitreomacular traction and macular holes. N Engl J Med. 2012 Aug 16;367(7):606-15. doi: 10.1056/NEJMoa1110823.

  PMID: 22894573 BACKGROUND

• Freund KB, Shah SA, Shah VP. Correlation of transient vision loss with outer retinal disruption following intravitreal ocriplasmin. Eye (Lond). 2013 Jun;27(6):773-4. doi: 10.1038/eye.2013.94. Epub 2013 May 3. No abstract available.

  PMID: 23640609 BACKGROUND

• Chan CK, Wessels IF, Friedrichsen EJ. Treatment of idiopathic macular holes by induced posterior vitreous detachment. Ophthalmology. 1995 May;102(5):757-67. doi: 10.1016/s0161-6420(95)30958-x.

  PMID: 7777275 BACKGROUND

• Jorge R, Costa RA, Cardillo JA, Uno F, Bonomo PP, Farah ME. Optical coherence tomography evaluation of idiopathic macular hole treatment by gas-assisted posterior vitreous detachment. Am J Ophthalmol. 2006 Nov;142(5):869-71. doi: 10.1016/j.ajo.2006.05.062.

  PMID: 17056375 BACKGROUND

• Mori K, Saito S, Gehlbach PL, Yoneya S. Treatment of stage 2 macular hole by intravitreous injection of expansile gas and induction of posterior vitreous detachment. Ophthalmology. 2007 Jan;114(1):127-33. doi: 10.1016/j.ophtha.2006.07.001. Epub 2006 Oct 27.

  PMID: 17070585 BACKGROUND

• Ochoa-Contreras D, Delsol-Coronado L, Buitrago ME, Velasco-Barona C, Quiroz-Mercado H. Induced posterior vitreous detachment by intravitreal sulfur hexafluoride (SF6) injection in patients with nonproliferative diabetic retinopathy. Acta Ophthalmol Scand. 2000 Dec;78(6):687-8. doi: 10.1034/j.1600-0420.2000.078006687.x.

  PMID: 11167234 BACKGROUND

• McHugh D, Gupta B, Saeed M. Intravitreal gas injection for the treatment of diabetic macular edema. Clin Ophthalmol. 2011;5:1543-8. doi: 10.2147/OPTH.S25348. Epub 2011 Oct 26.

  PMID: 22125399 BACKGROUND

• Kim YM, Lee SJ, Koh HJ. Gas-assisted release of vitreomacular adhesion in wet age-related macular degeneration. Retina. 2011 Nov;31(10):2123-4. doi: 10.1097/IAE.0B013E31822F5720. No abstract available.

  PMID: 22027799 BACKGROUND

• Rodrigues IA, Stangos AN, McHugh DA, Jackson TL. Intravitreal injection of expansile perfluoropropane (c(3)f(8)) for the treatment of vitreomacular traction. Am J Ophthalmol. 2013 Feb;155(2):270-276.e2. doi: 10.1016/j.ajo.2012.08.018. Epub 2012 Nov 17.

  PMID: 23164159 BACKGROUND

Related Links

• Northern California Retina Vitreous Associates

MeSH Terms

Conditions

Retinal Perforations; Epiretinal Membrane

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases

Study Officials

• Alok S Bansal, MD

  Northern California Retina Vitreous Associates

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 24, 2013
• First Posted: December 5, 2013
• Study Start: November 1, 2013
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: February 2, 2016

Record last verified: 2016-01

Locations

US (1)