Vitreomacular Adhesion Clinical Trial
Official title:
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.
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.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT01966328 -
A Safety and Efficacy Assessment of Resolvine for Treatment of Vitreomacular Attachment
|
Phase 1 | |
Completed |
NCT02322229 -
Ocriplasmin for Vitreomacular Traction/Symptomatic Vitreomacular Adhesion
|
Phase 4 | |
Completed |
NCT02160340 -
Prevalence of Vitreomacular Adhesion in Patients 40 Years and Older
|
||
Completed |
NCT00798317 -
Trial of Microplasmin Intravitreal Injection for Non-Surgical Treatment of Focal Vitreomacular Adhesion. The MIVI-TRUST (TG-MV-007) Trial.
|
Phase 3 | |
Completed |
NCT00781859 -
Trial of Microplasmin Intravitreal Injection for Non-surgical Treatment of Focal Vitreomacular Adhesion. The MIVI-TRUST (TG-MV-006) Trial.
|
Phase 3 | |
Completed |
NCT02035748 -
Assessment of Patients Treated With JETREA® for Vitreomacular Traction
|
Phase 4 |