JCHR

Title

Single-Arm Study Assessing the Effects of Pneumatic Vitreolysis on Macular Hole

Précis

Eyes with vitreomacular traction (VMT) and full-thickness macular holes(MH) will be enrolled into a non-randomized cohort treated with PVL to determine the proportion with VMT release and MH closure and to assess factors associated with success.

Investigational Device

Intraocular gas (C₃F₈) injection

Objectives

To obtain estimates of the proportion of eyes with MH closure of the inner retinal layers for eyes with VMT and full-thickness MHs treated with PVL.

Rationale

Understanding the rates of VMT release and MH closures in eyes with full-thickness MH treated with PVL is of interest. Surgery would result in nearly 100% hole closure and VMT release, making vitrectomy a poor control group choice. Spontaneous resolution of MH is highly unlikely, making an observation arm unnecessary.  Therefore, these eyes will be enrolled into a non-randomized cohort treated with PVL to assess the outcomes of treatment.

Study Design

Single-arm study

Number of Sites

Approximately 50 sites

Endpoint

Primary Outcome: Proportion of eyes with MH closure of the inner retinal layers without rescue treatment 

Key Secondary Outcomes: proportion of eyes with foveal VMT release, proportion of eyes with foveal VMT and vitreopapillary traction release, proportion of eyes requiring vitrectomy, proportion of eyes with foveal lucency, mean change in visual acuity, and ellipsoid zone changes. 

Key Safety Outcomes: retinal tear, retinal detachment, traumatic cataract, cataract extraction, vitreous hemorrhage, intraocular pressure (IOP) increase, and endophthalmitis.

Population

Key Inclusion Criteria

• Age = 18 years.
• Able and willing to avoid high altitude until gas resolution (approximately 6 to 8 weeks)
• For phakic patients, able and willing to avoid supine positioning until gas resolution (approximately 6 to 8 weeks)
• Able and willing to position face down for at least 50% of the time for at least 4 days post-injection
• At least 1 eye with:

o   Vitreomacular adhesion on OCT that is no larger than 3000 microns, confirmed by a central reading center

o   Full-thickness MH that is = 250 microns at the narrowest point as measured on OCT, confirmed by a central Reading Center

o   Best corrected E-ETDRS visual acuity equivalent of 20/25 to 20/400 

Key Exclusion Criteria

• Other condition that might affect visual acuity during the course of the study (e.g., retinal vein occlusion, advanced age-related macular degeneration, or macular edema induced by a condition other than VMT)
• High level myopia (-8.00 diopters or more myopic if phakic or retinal abnormalities consistent with pathologic myopia if phakic or pseudophakic)
• Prior gas injection, ocriplasmin injection, or intraocular injection for any reason
• Prior vitrectomy
• History of advanced glaucoma that contraindicates intraocular gas injection

Sample Size

50 eyes

Treatment Groups

C₃F₈ injection only

Participant Duration

24 weeks

Protocol Overview/Synopsis

Enrollment Visit*

1, 4, 8, and 24 weeks

E-ETDRS best corrected visual acuity ^a

X

X

OCT ^b

X

X

Eye exam ^c

X

X

Reading center eligibility confirmation ^d

X

Gas injection

X