Intravitreal Gas for Vitreomacular Adhesion (RELEASE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Northern California Retina Vitreous Associates
Sponsor:
Information provided by (Responsible Party):
Northern California Retina Vitreous Associates
ClinicalTrials.gov Identifier:
NCT02001701
First received: November 24, 2013
Last updated: November 28, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention
Vitreomacular Adhesion
Procedure: Intravitreal Injection of sulfahexafluoride gas

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intravitreal Injection of Expansile Sulfa Hexafluoride Gas for Symptomatic Vitreomacular Adhesion

Resource links provided by NLM:


Further study details as provided by Northern California Retina Vitreous Associates:

Primary Outcome Measures:
  • Proportion of patients with resolution of vitreomacular adhesion at Day 28 [ Time Frame: Day 28 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Visual Acuity [ Time Frame: Day 14 ] [ Designated as safety issue: No ]
  • Change in Visual Acuity [ Time Frame: Day 28 ] [ Designated as safety issue: No ]
  • Change in Visual Acuity [ Time Frame: Day 90 ] [ Designated as safety issue: No ]
  • Time to resolution of vitreomacular adhesion [ Time Frame: Day 90 ] [ Designated as safety issue: No ]
  • Proportion of patients requiring vitrectomy surgery [ Time Frame: Day 90 ] [ Designated as safety issue: No ]

    The investigator may consider vitrectomy surgery if:

    1. Decrease in Visual Acuity
    2. Worsening of vitreomacular adhesion on SD-OCT
    3. Progression of vitreomacular adhesion to macular hole
    4. No improvement of vitreomacular adhesion by Day 28

  • Incidence of Retinal Tears and Retinal Detachment [ Time Frame: Day 28 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: November 2013
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intravitreal Gas
Intravitreal injection of sulfahexafluoride gas
Procedure: Intravitreal Injection of sulfahexafluoride gas
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.

Detailed Description:

Symptomatic vitreomacular adhesion (sVMA), also known as Vitreomacular traction (VMT) is thought to occur due to an anomalous or incomplete posterior vitreous detachment (PVD).1 Typical symptoms of VMT include decreased reading vision and metamorphopsia. Ultra-high resolution spectral-domain optical coherence tomography (SD-OCT) has greatly enhanced our understanding of the spectrum of the vitreomacular interface disorders ranging from focal adhesions, macular cysts, impending macular holes, full thickness macular holes, lamellar holes, and epiretinal membrane.2 Generally, pars plana vitrectomy (PPV) surgery is the preferred treatment for many of these conditions with high success rates.3 However, surgical intervention is not without risk and includes the potential for infection, retinal detachment, cataract progression, and patient discomfort from post-operative prone positioning in cases of macular hole.4 Despite the high success rate with vitrectomy, the risks of surgery have led researchers to search for non-surgical treatments of VMT such as pharmacologic vitreolysis. Ocriplasmin (JetreaTM, ThromboGenics, Inc. Iselin, NJ) was recently approved by the United States Food & Drug Administration (FDA) in October 2012 as a non-surgical, pharmacologic agent for the treatment of symptomatic VMA.5 Pooled data from two phase III clinical trials of ocriplasmin (MIVI-TRUST)5 demonstrated that approximately 26% of eyes treated with a single intravitreal injection of ocriplasmin (125 ug) compared to 10% of eyes treated with vehicle alone (placebo) resulted in resolution of VMA on OCT at 28 days. Potential side effects of ocriplasmin include transient floaters, zonular instability, and transient vision loss.6 Although the primary outcome of the study achieved a statistically significant result compared to placebo, the less than robust results compared to surgical intervention with the associated high cost of the medication have led retina specialists to question the clinical utility of this medication.

Previous small case series' have demonstrated that an intravitreal gas bubble injection alone (i.e. pneumatic vitreolysis) may lead to macular hole closure through the induction of a PVD.7-9 Additional small cases series' have shown that an intravitreal gas bubble alone may induce a PVD in patients with non-proliferative diabetic retinopathy10 and diabetic macular edema11 in nearly 100% of cases. One small case series showed that an intravitreal gas bubble in combination with an anti-vascular endothelial growth factor agent can cause resolution of VMA in patients with wet macular degeneration in 4/4 (100%) of eyes.12 However, there is a paucity of literature on the specific treatment of isolated VMT with intravitreal gas alone. Recently, Rodriques et al13 demonstrated that a single intravitreal injection of perfluoropropane (C3F8) gas injection may cause VMT resolution in 5/7 (70%) eyes with isolated VMT and in 3/6 (50%) eyes with diabetic macular edema. Although this initial study demonstrated efficacy, the overall success rate of the procedure as well as the visual acuity benefit was limited due to the heterogeneous patient population. Pneumatic vitreolysis may offer a potential safe, low cost, and effective procedure that may pose an alternative to treatment in patients with symptomatic vitreomacular adhesion.

The purpose of the present study is to evaluate the efficacy and safety of the administration of a single intravitreal injection of sulfa hexafluoride (SF6) gas for patients with symptomatic vitreomacular adhesion without concomitant macular hole. Key differences between the present study and that by Rodriques et al.10 are the use of a shorter acting gas bubble (SF6 vs C3F8) and the inclusion of a homogenous patient population with VMA alone.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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:

    1. Symptoms: blurred vision, double vision, metamorphopsia, micropsia
    2. Snellen Visual Acuity: < 20/25 in study eye
  • SD-OCT (Cirrus, Car Zeiss Meditec, Dublin, CA) Findings:

    1. Visible vitreous attachment within a 1,500 um radius of the foveal center causing antero-posterior vitreofoveal traction with associated microstructural retinal changes
    2. See Figure 1 (Image "E") for representative candidates for inclusion.
  • Observation period of 1 month prior to intervention allowing for spontaneous resolution

Exclusion Criteria:

  • 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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02001701

Contacts
Contact: Lisa Aguda 650-988-7480

Locations
United States, California
Northern California Retina Vitreous Associates Recruiting
Mountain View, California, United States, 94040
Contact: Lisa Aguda    650-988-7480      
Principal Investigator: Alok Bansal, MD         
Sub-Investigator: Rahul N Khurana, MD         
Sub-Investigator: Louis Chang, MD PhD         
Sub-Investigator: Luigi Borrillo, MD         
Sub-Investigator: James Palmer, MD         
Sub-Investigator: Mark Wieland, MD         
Sub-Investigator: Edwin Boldrey, MD         
Sponsors and Collaborators
Northern California Retina Vitreous Associates
Investigators
Principal Investigator: Alok S Bansal, MD Northern California Retina Vitreous Associates
  More Information

Additional Information:
Publications:

Responsible Party: Northern California Retina Vitreous Associates
ClinicalTrials.gov Identifier: NCT02001701     History of Changes
Other Study ID Numbers: NCRVA - 2013 - RELEASE
Study First Received: November 24, 2013
Last Updated: November 28, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Northern California Retina Vitreous Associates:
vitreomacular adhesion
vitreomacular traction
macular hole
epiretinal membrane
intravitreal gas
sulfahexafluoride gas
perfluoropropane gas
ocriplasmin
vitrectomy

Additional relevant MeSH terms:
Tissue Adhesions
Cicatrix
Fibrosis
Pathologic Processes
Gastrins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014