CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 46 enrolled
Drug / intervention
Pneumatic Vitreolysis (C3F8 injection) +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03647267
NCT03647267Phase 3Completed
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Randomized Clinical Trial Assessing the Effects of Pneumatic Vitreolysis on Vitreomacular Traction

Jaeb Center for Health Research·interventional·Posted Aug 27, 2018·Updated Sep 21, 2022

In Brief

A Phase 3 clinical trial evaluating Pneumatic Vitreolysis (C3F8 injection) and Observation for Vitreomacular Traction. Completed, enrolled 46 participants across 41 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVitreomacular Traction
CountriesUnited States
CollaboratorsNational Institutes of Health (NIH), National Eye Institute (NEI)

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedAug 27, 2018
Enrollment StartOct 16, 2018
Primary CompletionAug 6, 2020
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 7.8 years ago

Interventions

Pneumatic Vitreolysis (C3F8 injection)device

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.

Observationother

No intervention; sham injection only