Effects of Pneumatic Vitreolysis on Vitreomacular Traction (AG)
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|ClinicalTrials.gov Identifier: NCT03647267|
Recruitment Status : Recruiting
First Posted : August 27, 2018
Last Update Posted : May 23, 2019
|Condition or disease||Intervention/treatment||Phase|
|Vitreomacular Traction||Device: Pneumatic Vitreolysis (C3F8 injection) Other: Observation||Phase 3|
Investigational Device: 0.3-mL intraocular gas (C3F8) injection
To compare the proportion of eyes with foveal VMT release on OCT after pneumatic vitreolysis with gas injection versus observation (sham injection) in eyes with VMT without an associated macular hole.
- To evaluate visual function outcomes at 24 weeks after gas injection is performed compared with sham injection.
Study Design: Multi-center, randomized clinical trial
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||124 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, 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.|
|Official Title:||Randomized Clinical Trial Assessing the Effects of Pneumatic Vitreolysis on Vitreomacular Traction|
|Actual Study Start Date :||October 16, 2018|
|Estimated Primary Completion Date :||April 30, 2020|
|Estimated Study Completion Date :||April 30, 2020|
Active Comparator: Pneumatic Vitreolysis
Participants randomized to the Pneumatic Vitreolysis arm will receive 0.3-mL intraocular injection of C3F8 gas.
Device: 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.
Placebo Comparator: Observation
Participants randomized to the observation group will receive a sham injection.
No intervention; sham injection only
- Proportion of eyes with foveal vitreomacular traction release [ Time Frame: 24 Weeks ]Assessed by optical coherence tomography. Only for participants that do not undergo rescue treatment (e.g., vitrectomy or ocriplasmin). Determined by masked grader at the central reading center.
- Proportion of eyes with foveal vitreomacular traction release (time-to-event analysis) [ Time Frame: Through 24 Weeks ]Assessed by optical coherence tomography by masked grader at a central reading center.
- Proportion of eyes with foveal vitreomacular traction release and vitreopapillary traction release [ Time Frame: 24 Weeks ]Assessed by optical coherence tomography by masked grader at a central reading center.
- Mean change in E-ETDRS visual acuity letter score [ Time Frame: From baseline at 24 weeks ]Visual acuity measured with the Electronic Early Treatment Study (E-ETDRS) visual acuity test. Unit of measure is based on the E-ETDRS letter score scale, 0-97, where 0 = worst and 97 = best.
- Proportion of eyes with at least 10-letter gain (increase) or loss (decrease) in visual acuity [ Time Frame: From baseline at 24 weeks ]Visual acuity measured with the Electronic Early Treatment Study (E-ETDRS) visual acuity test. Unit of measure is based on the E-ETDRS letter score scale, 0-97, where 0 = worst and 97 = best.
- Proportion of eyes receiving vitrectomy or for which vitrectomy is planned [ Time Frame: ≤ 24 Weeks ]Partipant must have vitrectomy before the 24-week visit or planned for at the 24-week visit with medical records confirming vitrectomy occurs within subsequent 12 weeks.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03647267
|Contact: Adam R Glassman, MSfirstname.lastname@example.org|
Show 39 Study Locations
|Study Chair:||Clement Chan, MD||Southern California Desert Retina Consultants, MC|