Intravitreal Gas for Vitreomacular Adhesion (RELEASE)
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.
Procedure: Intravitreal Injection of sulfahexafluoride gas
|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|
- Proportion of patients with resolution of vitreomacular adhesion at Day 28 [ Time Frame: Day 28 ] [ Designated as safety issue: No ]
- 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:
- Decrease in Visual Acuity
- Worsening of vitreomacular adhesion on SD-OCT
- Progression of vitreomacular adhesion to macular hole
- No improvement of vitreomacular adhesion by Day 28
- Incidence of Retinal Tears and Retinal Detachment [ Time Frame: Day 28 ] [ Designated as safety issue: Yes ]
|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)|
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02001701
|Contact: Lisa Aguda||650-988-7480|
|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|
|Principal Investigator:||Alok S Bansal, MD||Northern California Retina Vitreous Associates|