Vitreomacular Traction
Conditions
Brief summary
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.
Detailed description
Investigational Device: 0.3-mL intraocular gas (C3F8) injection Objectives Primary 1. To compare the proportion of eyes with central 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
Interventions
DEVICEPneumatic Vitreolysis (C3F8 injection)
Pneumatic Vitreolysis will be performed via an intraocular injection of C3F8 gas. Perfluoropropane (C3F8) is an inert gas under pressure and is administered by injection into the vitreous cavity. It was approved by the FDA in February 1993 (P900066) for the use of placing pressure on detached retina.
OTHERObservation
No intervention; sham injection only
Sponsors
National Institutes of Health (NIH)
National Eye Institute (NEI)
Jaeb Center for Health Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
Visual acuity and optical coherence tomography technicians will be masked to treatment group at all visits. The goal is for study participants to remain masked to their treatment group assignment, although it is likely that the gas bubble will be visible to participants in the pneumatic vitreolysis group. Investigators and study coordinators are not masked to treatment group.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of Eyes With Central Vitreomacular Traction Release Without Rescue Vitrectomy | at 24 Weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Eyes With Rescue Treatment Before the 24-week Visit | up to 24 weeks | — |
| Number of Eyes With Rescue Vitrectomy Completed Before the 24-week Visit or Planned at the 24 Week Visit | through 24 Weeks | scheduled rescue vitrectomy must be completed within the subsequent 12 weeks. |
| Number of Eyes With Central Vitreomacular Traction Status | up to 24 weeks | — |
| Mean Change in E-ETDRS Visual Acuity Letter Score From Baseline | Baseline to 24 weeks | Best-corrected visual acuity following protocol-defined refraction. Visual Acuity was measured with the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity test on a scale from 100 letters (Snellen equivalent of 20/10) to 0 letters (Snellen equivalent \<20/800). Higher scores indicate better visual acuity and lower scores indicate worse visual acuity. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pneumatic Vitreolysis (PVL) Pneumatic vitreolysis is an in-office intraocular injection of an expansile gas (C3F8) to induce release of vitreomacular traction. | 24 |
| Sham For sham injections, the hub of a needleless syringe was pressed against the conjunctival surface to simulate the pressure of an injection. | 22 |
| Total | 46 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 |
Baseline characteristics
| Characteristic | Pneumatic Vitreolysis (PVL) | Sham | Total |
|---|---|---|---|
| Age, Continuous | 70 years STANDARD_DEVIATION 10 | 75 years STANDARD_DEVIATION 8 | 72 years STANDARD_DEVIATION 9 |
| Diabetes Type No | 16 Participants | 12 Participants | 28 Participants |
| Diabetes Type Type 2 | 8 Participants | 10 Participants | 18 Participants |
| E-ETDRS visual acuity letter score | 67.8 units on a scale STANDARD_DEVIATION 10.3 | 69.2 units on a scale STANDARD_DEVIATION 8.4 | 68.5 units on a scale STANDARD_DEVIATION 9.4 |
| Epiretinal membrane in central subfield | 2 Eyes | 1 Eyes | 3 Eyes |
| Intraocular pressure | 15 mmHg STANDARD_DEVIATION 4 | 14 mmHg STANDARD_DEVIATION 3 | 15 mmHg STANDARD_DEVIATION 4 |
| Lens status on clinical exam Phakic (natural lens) | 14 Eyes | 9 Eyes | 23 Eyes |
| Lens status on clinical exam Posterior Chamber intraocular lens | 10 Eyes | 13 Eyes | 23 Eyes |
| Loss of ellipsoid zone integrity in central subfield | 15 Eyes | 8 Eyes | 23 Eyes |
| Loss of ellipsoid zone integrity in foveal center | 11 Eyes | 8 Eyes | 19 Eyes |
| Race/Ethnicity, Customized Hispanic or Latino | 4 Participants | 5 Participants | 9 Participants |
| Race/Ethnicity, Customized non-Hispanic Black/African American | 3 Participants | 0 Participants | 3 Participants |
| Race/Ethnicity, Customized Non-Hispanic White | 16 Participants | 17 Participants | 33 Participants |
| Race/Ethnicity, Customized Unknown or not reported | 1 Participants | 0 Participants | 1 Participants |
| Sex: Female, Male Female | 15 Participants | 16 Participants | 31 Participants |
| Sex: Female, Male Male | 9 Participants | 6 Participants | 15 Participants |
| Width of vitreomacular attachment that extends within the central subfield | 480 Microns | 503 Microns | 495 Microns |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 24 | 0 / 22 |
| other Total, other adverse events | 10 / 24 | 5 / 22 |
| serious Total, serious adverse events | 5 / 24 | 0 / 22 |
Outcome results
Primary
Proportion of Eyes With Central Vitreomacular Traction Release Without Rescue Vitrectomy
Time frame: at 24 Weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pneumatic Vitreolysis (PVL) | Proportion of Eyes With Central Vitreomacular Traction Release Without Rescue Vitrectomy | 78 percentage of eyes |
| Sham | Proportion of Eyes With Central Vitreomacular Traction Release Without Rescue Vitrectomy | 9 percentage of eyes |
Secondary
Mean Change in E-ETDRS Visual Acuity Letter Score From Baseline
Best-corrected visual acuity following protocol-defined refraction. Visual Acuity was measured with the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity test on a scale from 100 letters (Snellen equivalent of 20/10) to 0 letters (Snellen equivalent \<20/800). Higher scores indicate better visual acuity and lower scores indicate worse visual acuity.
Time frame: Baseline to 24 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pneumatic Vitreolysis (PVL) | Mean Change in E-ETDRS Visual Acuity Letter Score From Baseline | 6.7 units on a scale | Standard Deviation 12.4 |
| Sham | Mean Change in E-ETDRS Visual Acuity Letter Score From Baseline | 6.1 units on a scale | Standard Deviation 9.6 |
Secondary
Mean Change in E-ETDRS Visual Acuity Letter Score From Baseline
Best-corrected visual acuity following protocol-defined refraction. Visual Acuity was measured with the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity test on a scale from 100 letters (Snellen equivalent of 20/10) to 0 letters (Snellen equivalent \<20/800). Higher scores indicate better visual acuity and lower scores indicate worse visual acuity.
Time frame: Baseline to 24 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pneumatic Vitreolysis (PVL) | Mean Change in E-ETDRS Visual Acuity Letter Score From Baseline | 6.7 units on a scale | Standard Deviation 12.4 |
| Sham | Mean Change in E-ETDRS Visual Acuity Letter Score From Baseline | 6.1 units on a scale | Standard Deviation 9.6 |
Secondary
Number of Eyes With Central Vitreomacular Traction Status
Time frame: up to 24 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pneumatic Vitreolysis (PVL) | Number of Eyes With Central Vitreomacular Traction Status | Released with rescue vitrectomy | 1 Eyes |
| Pneumatic Vitreolysis (PVL) | Number of Eyes With Central Vitreomacular Traction Status | Not released and no rescue vitrectomy | 4 Eyes |
| Pneumatic Vitreolysis (PVL) | Number of Eyes With Central Vitreomacular Traction Status | Not released despite rescue vitrectomy | 0 Eyes |
| Pneumatic Vitreolysis (PVL) | Number of Eyes With Central Vitreomacular Traction Status | Released without rescue vitrectomy | 18 Eyes |
| Sham | Number of Eyes With Central Vitreomacular Traction Status | Released without rescue vitrectomy | 2 Eyes |
| Sham | Number of Eyes With Central Vitreomacular Traction Status | Released with rescue vitrectomy | 0 Eyes |
| Sham | Number of Eyes With Central Vitreomacular Traction Status | Not released despite rescue vitrectomy | 0 Eyes |
| Sham | Number of Eyes With Central Vitreomacular Traction Status | Not released and no rescue vitrectomy | 20 Eyes |
Secondary
Number of Eyes With Rescue Treatment Before the 24-week Visit
Time frame: up to 24 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pneumatic Vitreolysis (PVL) | Number of Eyes With Rescue Treatment Before the 24-week Visit | 1 Eyes |
| Sham | Number of Eyes With Rescue Treatment Before the 24-week Visit | 0 Eyes |
Secondary
Number of Eyes With Rescue Vitrectomy Completed Before the 24-week Visit or Planned at the 24 Week Visit
scheduled rescue vitrectomy must be completed within the subsequent 12 weeks.
Time frame: through 24 Weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pneumatic Vitreolysis (PVL) | Number of Eyes With Rescue Vitrectomy Completed Before the 24-week Visit or Planned at the 24 Week Visit | 1 Eyes |
| Sham | Number of Eyes With Rescue Vitrectomy Completed Before the 24-week Visit or Planned at the 24 Week Visit | 1 Eyes |