NCT03647267: AG

Effects of Pneumatic Vitreolysis on Vitreomacular Traction

Completed Phase 3 Results posted Last updated 21 September 2022

What this trial tests

Phase 3 trial testing Pneumatic Vitreolysis (C3F8 injection) in Vitreomacular Traction in 46 participants. Completed in 6 August 2020.

Timeline

16 October 2018

Primary endpoint
6 August 2020

6 August 2020

Quick facts

Lead sponsor	Jaeb Center for Health Research
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	46
Start date	16 October 2018
Primary completion	6 August 2020
Estimated completion	6 August 2020
Sites	41 locations across United States

Drugs / interventions tested

• Pneumatic Vitreolysis (C3F8 injection)
• Observation

Conditions studied

• Vitreomacular Traction — all drugs for Vitreomacular Traction →

Sponsor

Jaeb Center for Health Research — full company profile →

Who can join

18 and older, any sex, with Vitreomacular Traction. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Proportion of Eyes With Central Vitreomacular Traction Release Without Rescue Vitrectomy Primary · at 24 Weeks

Group	Value	95% CI
Pneumatic Vitreolysis (PVL)	78
Sham	9

Number of Eyes With Rescue Treatment Before the 24-week Visit Secondary · up to 24 weeks

Group	Value	95% CI
Pneumatic Vitreolysis (PVL)	1
Sham	0

Number of Eyes With Rescue Vitrectomy Completed Before the 24-week Visit or Planned at the 24 Week Visit Secondary · through 24 Weeks

scheduled rescue vitrectomy must be completed within the subsequent 12 weeks.

Group	Value	95% CI
Pneumatic Vitreolysis	1
Observation	1

Number of Eyes With Central Vitreomacular Traction Status Secondary · up to 24 weeks

Released without rescue vitrectomy

Group	Value	95% CI
Pneumatic Vitreolysis	18
Observation	2

Released with rescue vitrectomy

Group	Value	95% CI
Pneumatic Vitreolysis	1
Observation	0

Not released and no rescue vitrectomy

Group	Value	95% CI
Pneumatic Vitreolysis	4
Observation	20

Not released despite rescue vitrectomy

Group	Value	95% CI
Pneumatic Vitreolysis	0
Observation	0

Mean Change in E-ETDRS Visual Acuity Letter Score From Baseline Secondary · 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.

Group	Value	95% CI
Pneumatic Vitreolysis	6.7	± 12.4
Observation	6.1	± 9.6

Mean Change in E-ETDRS Visual Acuity Letter Score From Baseline Secondary · 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.

Group	Value	95% CI
Pneumatic Vitreolysis	6.7	± 12.4
Observation	6.1	± 9.6

Adverse events — posted to ClinicalTrials.gov

Time frame: 24- weeks. Reporting threshold: 0.01%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Pneumatic Vitreolysis

Serious: 5/24 (21%)

Deaths: 0/24

Observation

Serious: 0/22 (0%)

Deaths: 0/22

Serious adverse events (6 terms)

Reaction	System	Pneumatic Vitreolysis	Observation
Rhegmatogenous retinal detachment	Eye disorders	—	—
Cataract traumatic (ocular injury)	Eye disorders	—	—
Endophthalmitis	Eye disorders	—	—
Macular hole	Eye disorders	—	—
Retinal tear	Eye disorders	—	—
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	—	—

Other adverse events (22 terms — click to expand)

Reaction	System	Pneumatic Vitreolysis	Observation
Posterior vitreous detachment	Eye disorders	—	—
Cataract	Eye disorders	—	—
Ocular hypertension	Eye disorders	—	—
Subconjunctival hemorrhage	Eye disorders	—	—
Anterior chamber cell	Eye disorders	—	—
Anterior chamber flare	Eye disorders	—	—
Blurred vision	Eye disorders	—	—
Conjunctival hyperemia	Eye disorders	—	—
Corneal abrasion	Eye disorders	—	—
Corneal edema	Eye disorders	—	—
Epiretinal membrane	Eye disorders	—	—
Eye itching	Eye disorders	—	—
Eye pain	Eye disorders	—	—
Floaters	Eye disorders	—	—
Macular hole	Eye disorders	—	—
Nuclear sclerosis	Eye disorders	—	—
Posterior capsule opacification	Eye disorders	—	—
Stye	Eye disorders	—	—
Visual disturbances	Eye disorders	—	—
Visual flashes	Eye disorders	—	—
Vitreous debris	Eye disorders	—	—
Vitreous hemorrhage	Eye disorders	—	—

Most-reported serious reactions: Rhegmatogenous retinal detachment, Cataract traumatic (ocular injury), Endophthalmitis, Macular hole, Retinal tear, Acute respiratory failure.

Data from ClinicalTrials.gov NCT03647267 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Pneumatic Vitreolysis with Perfluoropropane for Vitreomacular Traction with and without Macular Hole: DRCR Retina Network Protocols AG and AH.
   Chan CK, Mein CE, Glassman AR, Beaulieu WT, et al · · 2021 · cited 28× · PMID 33989683 · DOI 10.1016/j.ophtha.2021.05.005