Intravitreal Gas for Vitreomacular Adhesion (RELEASE)

January 30, 2016 updated by: Northern California Retina Vitreous Associates

Intravitreal Injection of Expansile Sulfa Hexafluoride Gas for Symptomatic Vitreomacular Adhesion

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Mountain View, California, United States, 94040
        • Northern California Retina Vitreous Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients with resolution of vitreomacular adhesion at Day 28
Time Frame: Day 28
Day 28

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Visual Acuity
Time Frame: Day 14
Day 14
Change in Visual Acuity
Time Frame: Day 28
Day 28
Change in Visual Acuity
Time Frame: Day 90
Day 90
Time to resolution of vitreomacular adhesion
Time Frame: Day 90
Day 90
Proportion of patients requiring vitrectomy surgery
Time Frame: Day 90

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
Day 90
Incidence of Retinal Tears and Retinal Detachment
Time Frame: Day 28
Day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northern California Retina Vitreous Associates

Investigators

  • Principal Investigator: Alok S Bansal, MD, Northern California Retina Vitreous Associates

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Anticipated)

June 1, 2015

Study Completion (Anticipated)

June 1, 2015

Study Registration Dates

First Submitted

November 24, 2013

First Submitted That Met QC Criteria

November 28, 2013

First Posted (Estimate)

December 5, 2013

Study Record Updates

Last Update Posted (Estimate)

February 2, 2016

Last Update Submitted That Met QC Criteria

January 30, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCRVA - 2013 - RELEASE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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