NCT03677869: Protocol AH

Effects of Pneumatic Vitreolysis on Macular Hole

Completed NA Results posted Last updated 19 September 2022

What this trial tests

NA trial testing Intraocular gas (C3F8) in Vitreomacular Traction (VMT) in 36 participants. Completed in 22 July 2020.

Timeline

14 November 2018

Primary endpoint
16 March 2020

22 July 2020

Quick facts

Lead sponsor	Jaeb Center for Health Research
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	36
Start date	14 November 2018
Primary completion	16 March 2020
Estimated completion	22 July 2020
Sites	45 locations across United States

Drugs / interventions tested

• Intraocular gas (C3F8)

Conditions studied

• Vitreomacular Traction (VMT) — all drugs for Vitreomacular Traction (VMT) →
• Full-thickness Macular Holes (MH) — all drugs for Full-thickness Macular Holes (MH) →

Sponsor

Jaeb Center for Health Research — full company profile →

Who can join

18 and older, any sex, with Vitreomacular Traction (VMT) or Full-thickness Macular Holes (MH). 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 Macular Hole Closure of Inner Retinal Layers Without Rescue Vitrectomy Primary · at 8 weeks

Group	Value	95% CI
Pneumatic Vitreolysis (PVL)	10

Mean Change in E-ETDRS Visual Acuity Letter Score From Baseline Secondary · Baseline to 8 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 (PVL)	-1.5	± 25.6

E-ETDRS Visual Acuity Letter Score Secondary · 8 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 (PVL)	54.2	± 23.8

Number of Eyes With Rescue Treatment Before the 8-week Visit Secondary · up to 8 Weeks

Group	Value	95% CI
Pneumatic Vitreolysis (PVL)	12

Macular Hole Closure Without Rescue Vitrectomy Secondary · 8 Weeks

Group	Value	95% CI
Pneumatic Vitreolysis (PVL)	10

Macular Hole Closure With Rescue Vitrectomy Secondary · 8 weeks

Group	Value	95% CI
Pneumatic Vitreolysis (PVL)	10

No Macular Hole Closure and no Rescue Vitrectomy Secondary · 8 weeks

Group	Value	95% CI
Pneumatic Vitreolysis (PVL)	13

No Macular Hole Closure Despite Rescue Vitrectomy Secondary · 8 weeks

Group	Value	95% CI
Pneumatic Vitreolysis (PVL)	2

Adverse events — posted to ClinicalTrials.gov

Time frame: 24-Weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Pneumatic Vitreolysis (PVL)

Serious: 5/35 (14%)

Deaths: 0/35

Serious adverse events (3 terms)

Reaction	System	Pneumatic Vitreolysis (PVL)
Rhegmatogenous retinal detachment	Eye disorders	—
Retinal tear	Eye disorders	—
Embolism - blood clot	Vascular disorders	—

Other adverse events (23 terms — click to expand)

Reaction	System	Pneumatic Vitreolysis (PVL)
Ocular hypertension	Eye disorders	—
Subconjunctival hemorrhage	Eye disorders	—
Macular hole	Eye disorders	—
Posterior vitreous detachment	Eye disorders	—
Anterior chamber cell	Eye disorders	—
Anterior chamber opacity	Eye disorders	—
Cataract	Eye disorders	—
Corneal abrasion	Eye disorders	—
Corneal defect	Eye disorders	—
Corneal edema	Eye disorders	—
Corneal pigmentation	Eye disorders	—
Dry eye	Eye disorders	—
Eye irritation	Eye disorders	—
Eye itching	Eye disorders	—
Eye pain	Eye disorders	—
Floaters	Eye disorders	—
Ocular discomfort	Eye disorders	—
Posterior capsule opacification	Eye disorders	—
Red eye	Eye disorders	—
Visual acuity decreased	Eye disorders	—
Visual flashes	Eye disorders	—
Vitreous debris	Eye disorders	—
Vitreous hemorrhage	Eye disorders	—

Most-reported serious reactions: Rhegmatogenous retinal detachment, Retinal tear, Embolism - blood clot.

Data from ClinicalTrials.gov NCT03677869 adverse events section.

Sponsor's own description

Eyes with vitreomacular traction (VMT) and full-thickness macular holes (MH) will be enrolled into a non-randomized cohort treated with pneumatic vitreolysis (PVL) to determine the proportion with VMT release and MH closure and to assess factors associated with success.

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