Full Protocol
Summary Slides for AG & AH
Informed Consent Form
Protocol Summary
| Participant area | description |
| Title | Randomized Clinical Trial Assessing the Effects of Pneumatic Vitreolysis on Vitreomacular Traction |
| Précis | Eyes with idiopathic symptomatic vitreomacular traction (VMT) without a macular hole will be randomly assigned to 0.3-mL intraocular gas (C3F8) injection or sham injection to determine if pneumatic vitreolysis (PVL) is effective in releasing VMT. |
| Investigational Device | 0.3-mL intraocular gas (C3F8) injection |
| Objectives | Primary - 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 - To evaluate visual function outcomes at 24 weeks after gas injection is performed compared with sham injection.
|
| Study Design | Multi-center, randomized clinical trial |
| Number of Sites | Approximately 50 sites |
| Endpoint | Primary Outcome: Proportion of eyes with foveal VMT release on optical coherence tomography (OCT) without rescue treatment at 24 weeks. Key Secondary Outcomes: Mean change in visual acuity, mean change in shape discrimination hyperacuity (SDH) (logMAR), proportion of eyes with rescue vitrectomy, proportion of eyes with resolution of vitreopapillary traction, and ellipsoid zone changes. Key Safety Outcomes: Retinal tear, retinal detachment, macular hole development, traumatic cataract, cataract extraction, vitreous hemorrhage, intraocular pressure (IOP) increase, endophthalmitis. |
| Population | Key Inclusion Criteria - Age =18 years.
- Able and willing to avoid high altitude travel 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).
- At least one eye with each of the following:
o vitreomacular adhesion on OCT that is no larger than 3000 microns, confirmed by central reading center, o decreased visual function (e.g. metamorphopsia or other visual symptom) that is attributed to VMT, o best corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity equivalent of 20/32 to 20/400, and o prompt vitrectomy not required Key Exclusion Criteria - Macular or lamellar hole.
- 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).
o Note: Epiretinal membrane is not an exclusion nor a requirement. - High level myopia (-8.00 diopters or more negative if phakic; retinal abnormalities consistent with pathologic myopia if phakic or pseudophakic).
- Prior gas injection, ocriplasmin injection, or intraocular injection for any reason.
- Prior vitrectomy.
|
| Sample Size | Minimum of 124 eyes |
| Treatment Groups | Random assignment (1:1) to one of the following: Group A: PVL (0.3-mL C3F8 injection) Group B: Observation (Sham injection) |
| Participant Duration | 24 weeks |
| Protocol Overview/Synopsis | - Informed consent will be obtained for screening
- Eligibility will be assessed, including reading center confirmation of VMT on OCT.
- Eligible eyes will be randomly assigned to C3F8 injection (0.3 mL) or sham injection, which will be performed on the day of randomization
- Follow-up will occur at 1, 4, 12 and 24 weeks and consist of vision testing (including visual acuity and visual function (myVisionTrack), ocular exam, and OCT
- Rescue vitrectomy may be performed if there is a 10 or more letter decrease at one visit or 5 or more letter decrease at two consecutive visits compared with baseline that is thought to be associated with VMT, or a complication that requires prompt surgical intervention (e.g. macular hole, retinal detachment, non-clearing vitreous hemorrhage). Otherwise, alternative treatment may not be performed without discussion with and approval from the protocol chair or designee
- The primary outcome assessment will be the proportion of eyes with foveal VMT release on OCT at 24 weeks without rescue treatment
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Schematic of Study Design
Follow-Up Treatment Vitrectomy permitted in both arms if one of the following: - Visual acuity decreases =10 letters at one visit or =5 letters at 2 consecutive visits (not including the 1-week visit) compared with baseline that is thought to be related to VMT.
- Complication requires prompt surgical intervention (e.g., macular hole, retinal detachment, non-clearing vitreous hemorrhage).
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Follow-Up Treatment Vitrectomy permitted in both arms if one of the following: - Visual acuity decreases =10 letters at one visit or =5 letters at two consecutive visits
- Complication requires prompt surgical intervention (e.g., macular hole)
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Schedule of Study Visits and Procedures
| | Baseline Testing and Randomization* | 1 and 4 weeks | 12 and 24 weeks |
| | X | X | X |
| | X | | X |
| | X | X | X |
| Eye exam d | X | X | X |
| Reading center eligibility confirmation e | X | | |
| Randomized treatment (gas or sham injection) | X | | |
* All baseline testing must occur within 8 days prior to randomization. Baseline testing and randomization can occur on the same day if eligibility is confirmed by reading center on day of screening.
a. Both eyes at all visits; includes protocol refraction in study eye only at 1, 4, and 12 weeks and in both eyes at baseline and 24 weeks; E-ETDRS refers to electronic ETDRS testing using the Electronic Visual Acuity Tester that has been validated against 4-meter chart ETDRS testing.
b. At baseline, 12, and 24 weeks.
c. Both eyes at baseline; study eye only at follow up visits.
d. Both eyes at baseline; study eye only at each follow-up visit. Includes slit lamp exam (including assessment of lens), measurement of IOP, and dilated ophthalmoscopy. Scleral depression is required at baseline to confirm eligibility. During follow up, the eye exam should be extensive enough to identify adverse events of interest.
e. Reading center review of the OCT for eligibility must occur prior to randomization.