Trial Outcomes & Findings for Effects of Pneumatic Vitreolysis on Vitreomacular Traction (NCT NCT03647267)
NCT ID: NCT03647267
Last Updated: 2022-09-21
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
46 participants
Primary outcome timeframe
at 24 Weeks
Results posted on
2022-09-21
Participant Flow
Unit of analysis: Eyes
Participant milestones
| Measure |
Pneumatic Vitreolysis (PVL)
Pneumatic vitreolysis is an in-office intraocular injection of an expansile gas (C3F8) to induce release of vitreomacular traction.
|
Sham
For sham injections, the hub of a needleless syringe was pressed against the conjunctival surface to simulate the pressure of an injection.
|
|---|---|---|
|
Overall Study
STARTED
|
24 24
|
22 22
|
|
Overall Study
COMPLETED
|
23 23
|
22 22
|
|
Overall Study
NOT COMPLETED
|
1 1
|
0 0
|
Reasons for withdrawal
| Measure |
Pneumatic Vitreolysis (PVL)
Pneumatic vitreolysis is an in-office intraocular injection of an expansile gas (C3F8) to induce release of vitreomacular traction.
|
Sham
For sham injections, the hub of a needleless syringe was pressed against the conjunctival surface to simulate the pressure of an injection.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
Effects of Pneumatic Vitreolysis on Vitreomacular Traction
Baseline characteristics by cohort
| Measure |
Pneumatic Vitreolysis (PVL)
n=24 Participants
Pneumatic vitreolysis is an in-office intraocular injection of an expansile gas (C3F8) to induce release of vitreomacular traction.
|
Sham
n=22 Participants
For sham injections, the hub of a needleless syringe was pressed against the conjunctival surface to simulate the pressure of an injection.
|
Total
n=46 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race/Ethnicity, Customized
non-Hispanic Black/African American
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown or not reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Diabetes Type
No
|
16 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Diabetes Type
Type 2
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Age, Continuous
|
70 years
STANDARD_DEVIATION 10 • n=5 Participants
|
75 years
STANDARD_DEVIATION 8 • n=7 Participants
|
72 years
STANDARD_DEVIATION 9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic White
|
16 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
E-ETDRS visual acuity letter score
|
67.8 units on a scale
STANDARD_DEVIATION 10.3 • n=5 Participants
|
69.2 units on a scale
STANDARD_DEVIATION 8.4 • n=7 Participants
|
68.5 units on a scale
STANDARD_DEVIATION 9.4 • n=5 Participants
|
|
Intraocular pressure
|
15 mmHg
STANDARD_DEVIATION 4 • n=5 Participants
|
14 mmHg
STANDARD_DEVIATION 3 • n=7 Participants
|
15 mmHg
STANDARD_DEVIATION 4 • n=5 Participants
|
|
Lens status on clinical exam
Phakic (natural lens)
|
14 Eyes
n=5 Participants
|
9 Eyes
n=7 Participants
|
23 Eyes
n=5 Participants
|
|
Lens status on clinical exam
Posterior Chamber intraocular lens
|
10 Eyes
n=5 Participants
|
13 Eyes
n=7 Participants
|
23 Eyes
n=5 Participants
|
|
Epiretinal membrane in central subfield
|
2 Eyes
n=5 Participants
|
1 Eyes
n=7 Participants
|
3 Eyes
n=5 Participants
|
|
Width of vitreomacular attachment that extends within the central subfield
|
480 Microns
n=5 Participants
|
503 Microns
n=7 Participants
|
495 Microns
n=5 Participants
|
|
Loss of ellipsoid zone integrity in central subfield
|
15 Eyes
n=5 Participants
|
8 Eyes
n=7 Participants
|
23 Eyes
n=5 Participants
|
|
Loss of ellipsoid zone integrity in foveal center
|
11 Eyes
n=5 Participants
|
8 Eyes
n=7 Participants
|
19 Eyes
n=5 Participants
|
PRIMARY outcome
Timeframe: at 24 WeeksOutcome measures
| Measure |
Pneumatic Vitreolysis (PVL)
n=23 Participants
Pneumatic vitreolysis is an in-office intraocular injection of an expansile gas (C3F8) to induce release of vitreomacular traction.
|
Sham
n=22 Eyes
For sham injections, the hub of a needleless syringe was pressed against the conjunctival surface to simulate the pressure of an injection.
|
|---|---|---|
|
Proportion of Eyes With Central Vitreomacular Traction Release Without Rescue Vitrectomy
|
78 percentage of eyes
|
9 percentage of eyes
|
SECONDARY outcome
Timeframe: up to 24 weeksOutcome measures
| Measure |
Pneumatic Vitreolysis (PVL)
n=23 Eyes
Pneumatic vitreolysis is an in-office intraocular injection of an expansile gas (C3F8) to induce release of vitreomacular traction.
|
Sham
n=22 Eyes
For sham injections, the hub of a needleless syringe was pressed against the conjunctival surface to simulate the pressure of an injection.
|
|---|---|---|
|
Number of Eyes With Rescue Treatment Before the 24-week Visit
|
1 Eyes
|
0 Eyes
|
SECONDARY outcome
Timeframe: through 24 Weeksscheduled rescue vitrectomy must be completed within the subsequent 12 weeks.
Outcome measures
| Measure |
Pneumatic Vitreolysis (PVL)
n=23 Eyes
Pneumatic vitreolysis is an in-office intraocular injection of an expansile gas (C3F8) to induce release of vitreomacular traction.
|
Sham
n=22 Eyes
For sham injections, the hub of a needleless syringe was pressed against the conjunctival surface to simulate the pressure of an injection.
|
|---|---|---|
|
Number of Eyes With Rescue Vitrectomy Completed Before the 24-week Visit or Planned at the 24 Week Visit
|
1 Eyes
|
1 Eyes
|
SECONDARY outcome
Timeframe: up to 24 weeksOutcome measures
| Measure |
Pneumatic Vitreolysis (PVL)
n=23 Eyes
Pneumatic vitreolysis is an in-office intraocular injection of an expansile gas (C3F8) to induce release of vitreomacular traction.
|
Sham
n=22 Eyes
For sham injections, the hub of a needleless syringe was pressed against the conjunctival surface to simulate the pressure of an injection.
|
|---|---|---|
|
Number of Eyes With Central Vitreomacular Traction Status
Released without rescue vitrectomy
|
18 Eyes
|
2 Eyes
|
|
Number of Eyes With Central Vitreomacular Traction Status
Released with rescue vitrectomy
|
1 Eyes
|
0 Eyes
|
|
Number of Eyes With Central Vitreomacular Traction Status
Not released and no rescue vitrectomy
|
4 Eyes
|
20 Eyes
|
|
Number of Eyes With Central Vitreomacular Traction Status
Not released despite rescue vitrectomy
|
0 Eyes
|
0 Eyes
|
SECONDARY outcome
Timeframe: Baseline to 24 weeksBest-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.
Outcome measures
| Measure |
Pneumatic Vitreolysis (PVL)
n=23 Eyes
Pneumatic vitreolysis is an in-office intraocular injection of an expansile gas (C3F8) to induce release of vitreomacular traction.
|
Sham
n=22 Eyes
For sham injections, the hub of a needleless syringe was pressed against the conjunctival surface to simulate the pressure of an injection.
|
|---|---|---|
|
Mean Change in E-ETDRS Visual Acuity Letter Score From Baseline
|
6.7 units on a scale
Standard Deviation 12.4
|
6.1 units on a scale
Standard Deviation 9.6
|
SECONDARY outcome
Timeframe: Baseline to 24 weeksBest-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.
Outcome measures
| Measure |
Pneumatic Vitreolysis (PVL)
n=23 Eyes
Pneumatic vitreolysis is an in-office intraocular injection of an expansile gas (C3F8) to induce release of vitreomacular traction.
|
Sham
n=22 Eyes
For sham injections, the hub of a needleless syringe was pressed against the conjunctival surface to simulate the pressure of an injection.
|
|---|---|---|
|
Mean Change in E-ETDRS Visual Acuity Letter Score From Baseline
|
6.7 units on a scale
Standard Deviation 12.4
|
6.1 units on a scale
Standard Deviation 9.6
|
Adverse Events
Pneumatic Vitreolysis
Serious events: 5 serious events
Other events: 10 other events
Deaths: 0 deaths
Observation
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pneumatic Vitreolysis
n=24 participants at risk
Participants randomized to the Pneumatic Vitreolysis arm will receive 0.3-mL intraocular injection of C3F8 gas.
Pneumatic 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.
|
Observation
n=22 participants at risk
Participants randomized to the observation group will receive a sham injection.
Observation: No intervention; sham injection only
|
|---|---|---|
|
Eye disorders
Cataract traumatic (ocular injury)
|
4.2%
1/24 • Number of events 1 • 24- weeks
|
0.00%
0/22 • 24- weeks
|
|
Eye disorders
Endophthalmitis
|
4.2%
1/24 • Number of events 1 • 24- weeks
|
0.00%
0/22 • 24- weeks
|
|
Eye disorders
Macular hole
|
4.2%
1/24 • Number of events 1 • 24- weeks
|
0.00%
0/22 • 24- weeks
|
|
Eye disorders
Retinal tear
|
4.2%
1/24 • Number of events 1 • 24- weeks
|
0.00%
0/22 • 24- weeks
|
|
Eye disorders
Rhegmatogenous retinal detachment
|
8.3%
2/24 • Number of events 3 • 24- weeks
|
0.00%
0/22 • 24- weeks
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
4.2%
1/24 • Number of events 1 • 24- weeks
|
0.00%
0/22 • 24- weeks
|
Other adverse events
| Measure |
Pneumatic Vitreolysis
n=24 participants at risk
Participants randomized to the Pneumatic Vitreolysis arm will receive 0.3-mL intraocular injection of C3F8 gas.
Pneumatic 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.
|
Observation
n=22 participants at risk
Participants randomized to the observation group will receive a sham injection.
Observation: No intervention; sham injection only
|
|---|---|---|
|
Eye disorders
Anterior chamber cell
|
4.2%
1/24 • Number of events 1 • 24- weeks
|
0.00%
0/22 • 24- weeks
|
|
Eye disorders
Anterior chamber flare
|
4.2%
1/24 • Number of events 1 • 24- weeks
|
0.00%
0/22 • 24- weeks
|
|
Eye disorders
Blurred vision
|
0.00%
0/24 • 24- weeks
|
4.5%
1/22 • Number of events 1 • 24- weeks
|
|
Eye disorders
Cataract
|
8.3%
2/24 • Number of events 2 • 24- weeks
|
0.00%
0/22 • 24- weeks
|
|
Eye disorders
Conjunctival hyperemia
|
0.00%
0/24 • 24- weeks
|
4.5%
1/22 • Number of events 1 • 24- weeks
|
|
Eye disorders
Corneal abrasion
|
0.00%
0/24 • 24- weeks
|
4.5%
1/22 • Number of events 1 • 24- weeks
|
|
Eye disorders
Corneal edema
|
4.2%
1/24 • Number of events 1 • 24- weeks
|
0.00%
0/22 • 24- weeks
|
|
Eye disorders
Epiretinal membrane
|
4.2%
1/24 • Number of events 1 • 24- weeks
|
0.00%
0/22 • 24- weeks
|
|
Eye disorders
Eye itching
|
4.2%
1/24 • Number of events 1 • 24- weeks
|
0.00%
0/22 • 24- weeks
|
|
Eye disorders
Eye pain
|
4.2%
1/24 • Number of events 1 • 24- weeks
|
0.00%
0/22 • 24- weeks
|
|
Eye disorders
Floaters
|
4.2%
1/24 • Number of events 1 • 24- weeks
|
0.00%
0/22 • 24- weeks
|
|
Eye disorders
Macular hole
|
0.00%
0/24 • 24- weeks
|
4.5%
1/22 • Number of events 1 • 24- weeks
|
|
Eye disorders
Nuclear sclerosis
|
4.2%
1/24 • Number of events 1 • 24- weeks
|
0.00%
0/22 • 24- weeks
|
|
Eye disorders
Ocular hypertension
|
8.3%
2/24 • Number of events 2 • 24- weeks
|
0.00%
0/22 • 24- weeks
|
|
Eye disorders
Posterior capsule opacification
|
4.2%
1/24 • Number of events 1 • 24- weeks
|
0.00%
0/22 • 24- weeks
|
|
Eye disorders
Posterior vitreous detachment
|
12.5%
3/24 • Number of events 3 • 24- weeks
|
0.00%
0/22 • 24- weeks
|
|
Eye disorders
Stye
|
0.00%
0/24 • 24- weeks
|
4.5%
1/22 • Number of events 1 • 24- weeks
|
|
Eye disorders
Subconjunctival hemorrhage
|
8.3%
2/24 • Number of events 2 • 24- weeks
|
0.00%
0/22 • 24- weeks
|
|
Eye disorders
Visual disturbances
|
4.2%
1/24 • Number of events 1 • 24- weeks
|
0.00%
0/22 • 24- weeks
|
|
Eye disorders
Visual flashes
|
0.00%
0/24 • 24- weeks
|
4.5%
1/22 • Number of events 1 • 24- weeks
|
|
Eye disorders
Vitreous debris
|
4.2%
1/24 • Number of events 1 • 24- weeks
|
0.00%
0/22 • 24- weeks
|
|
Eye disorders
Vitreous hemorrhage
|
4.2%
1/24 • Number of events 1 • 24- weeks
|
0.00%
0/22 • 24- weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place