Effects of Pneumatic Vitreolysis on Vitreomacular Traction

Investigational Device: 0.3-mL intraocular gas (C3F8) injection

Objectives

Primary

1. To compare the proportion of eyes with foveal VMT release on OCT after pneumatic
vitreolysis with gas injection versus observation (sham injection) in eyes with VMT
without an associated macular hole.

Secondary

2. To evaluate visual function outcomes at 24 weeks after gas injection is performed
compared with sham injection.

Study Design: Multi-center, randomized clinical trial

Inclusion Criteria:

1. At least one eye meets the study eye criteria listed below.

2. Able and willing to provide informed consent.

3. Able and willing to avoid high altitude travel, including airline travel, until gas
resolution (approximately 6 to 8 weeks).

4. For phakic patients, able and willing to avoid supine position until gas resolution
(approximately 6 to 8 weeks).

5. Able and willing to wear wristband that informs any medical personnel that the patient
has a gas bubble in the eye

Exclusion

A potential participant is not eligible if any of the following exclusion criteria are
present:

6. A condition that, in the opinion of the investigator, would preclude participation in
the study (e.g., unstable medical status that might preclude completion of follow-up)

7. Participation in an investigational trial within 30 days of randomization that
involves treatment with any drug or device that has not received regulatory approval
for the indication being studied at the time of study entry

• Note: study participants should not receive another investigational drug/device
while participating in the study

8. Known contraindication to any component of the treatment

9. Known allergy to any drug used in the procedure prep (including povidone iodine)

10. Potential participant is expecting to move out of the area of the clinical center to
an area not covered by another clinical center during the next 6 months following
randomization

11. Anticipated surgery requiring anesthesia within the next 6 months following
randomization

• Participants cannot receive nitrous oxide until gas resolution

12. For women of child-bearing potential, pregnant at the time of enrollment

• Women who are potential study participants should be questioned about the potential
for pregnancy. Investigator judgement may be used to determine when a pregnancy test
is needed.

Study Eye Criteria

The participant must have at least one eye meeting all of the inclusion criteria and
none of the exclusion criteria listed below.

A participant can have only one study eye. If both eyes are eligible at the time of
randomization, the study eye will be selected by the investigator and participant
before randomization.

The eligibility criteria for a study eye are as follows:

Inclusion

1. Vitreomacular adhesion on OCT that is no larger than 3000 microns with visible
separation of the vitreous on either side as seen on horizontal and vertical
scans, confirmed by central reading center Note: presence of epiretinal membrane
is neither a requirement nor exclusion.

2. Decreased visual function (e.g. metamorphopsia or other visual symptom) that is
attributed to VMT.

Examples of visual symptoms include:

a) Distortion and/or reduction in visual acuity b) Recognized difficulty with reading,
driving, or using a computer c) Patient recognized interference with quality of life
because of a and/or b.

c. Visual acuity letter score of at least 19 (approximate Snellen equivalent 20/400 or
better) and at most 78 (20/32 or worse) d. Investigator and participant willing to
wait 6 months before surgical intervention, provided visual acuity remains stable

• An eye that requires prompt treatment for VMT should not be enrolled

Exclusion e. Other ocular condition that might affect visual acuity during the course
of the study or require intraocular treatment (e.g., retinal vein occlusion,
substantial age-related macular degeneration, or macular edema induced by a condition
other than VMT) • If diabetic retinopathy is present, severity level must be
microaneurysms only or better (≤ diabetic retinopathy severity level 20)

• Presence of drusen is acceptable; however, eyes with geographic atrophy or
neovascular age-related macular degeneration involving the macula are excluded f. High
level of myopia (spherical equivalent of -8.00 diopters or more myopic if phakic or
retinal abnormalities consistent with pathologic myopia if phakic or pseudophakic) g.
History of prior gas injection, ocriplasmin injection, or intraocular injection for
any reason h. History of prior vitrectomy i. History of uncontrolled glaucoma

• IOP must be <30 mmHg, with no more than one topical glaucoma medication, and no
documented glaucomatous field loss for the eye to be eligible j. History of major
ocular surgery (including cataract extraction, scleral buckle, any intraocular
surgery, etc.) within prior 4 months or major ocular surgery anticipated within the
next 6 months following randomization k. History of YAG capsulotomy performed within 4
months prior to randomization l. Aphakia or anterior chamber intraocular lens m. Exam
evidence of severe external ocular infection, including conjunctivitis, chalazion, or
substantial blepharitis n. Uveitis o. Presence of any macular hole or lamellar hole
(according to reading center grading) p. Retinal history or pathology that might
predispose an eye to an increased risk of retinal detachment from the procedure

• Untreated retinal tears, not retinal holes, are an exclusion. It is up to the
investigator to determine whether extent of lattice degeneration or other pathology
might increase the risk of retinal detachment.

q. Any contraindication to paracentesis (e.g., history of narrow angle glaucoma) r.
Lenticular or zonular instability