Full-thickness Macular Holes (MH), Vitreomacular Traction (VMT)
Conditions
Keywords
Pneumatic Vitreolysis
Brief summary
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.
Detailed description
The objective of this trial is to obtain estimates of the proportion of eyes with MH closure of the inner retinal layers for eyes with VMT and full-thickness MHs treated with PVL. Understanding the rates of VMT release and MH closures in eyes with full-thickness MH treated with PVL is of interest. Surgery would result in nearly 100% hole closure and VMT release, making vitrectomy a poor control group choice. Spontaneous resolution of MH is highly unlikely, making an observation arm unnecessary. Therefore, these eyes will be enrolled into a non-randomized cohort treated with PVL to assess the outcomes of treatment.
Interventions
DEVICEIntraocular gas (C3F8)
Intraocular gas (C3F8) injection
Sponsors
National Institutes of Health (NIH)
National Eye Institute (NEI)
Jaeb Center for Health Research
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Participant-Level Criteria Inclusion To be eligible, the following inclusion criteria must be met: 1. Age ≥ 18 years • Participants \< 18 years old are not being included because the condition is so rare in this age group that the diagnosis may be questionable. 2. At least one eye meets the study eye criteria 3. Able and willing to provide informed consent 4. Able and willing to avoid high altitude travel, including airline travel, until gas resolution (approximately 6 to 8 weeks) 5. For phakic patients, able and willing to avoid supine position until gas resolution (approximately 6 to 8 weeks) 6. Able and willing to position face down for at least 50% of the time for at least 4 days post-injection (to facilitate macular hole closure) 7. Able and willing to wear wristband that informs any medical personnel that the patient has a gas bubble in the eye Exclusion A potential participant is not eligible if any of the following
Exclusion criteria
are present: 8\. A condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status that might preclude completion of follow up) 9. Participation in an investigational trial within 30 days of enrollment that involves treatment with any drug or device that has not received regulatory approval for the indication being studied at the time of study entry * Note: study participants should not receive another investigational drug or device while participating in the study 10. Known contraindication to any component of the treatment 11. Known allergy to any drug used in the procedure prep (including povidone iodine) 12. Potential participant is expecting to move out of the area of the clinical center to an area not covered by another clinical center during the 6 months following enrollment 13. Anticipated surgery requiring anesthesia within the 6 months following enrollment * Participants cannot receive nitrous oxide until gas resolution 13. For women of child-bearing potential: pregnant at the time of enrollment * Women who are potential study participants should be questioned about the potential for pregnancy. Investigator judgement may be used to determine when a pregnancy test is needed Study Eye Criteria The participant must have at least one eye meeting all of the inclusion criteria and none of the
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of Eyes With Macular Hole Closure of Inner Retinal Layers Without Rescue Vitrectomy | at 8 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| E-ETDRS Visual Acuity Letter Score | 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. |
| Number of Eyes With Rescue Treatment Before the 8-week Visit | up to 8 Weeks | — |
| Macular Hole Closure Without Rescue Vitrectomy | 8 Weeks | — |
| Mean Change in E-ETDRS Visual Acuity Letter Score From Baseline | 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. |
| No Macular Hole Closure and no Rescue Vitrectomy | 8 weeks | — |
| No Macular Hole Closure Despite Rescue Vitrectomy | 8 weeks | — |
| Macular Hole Closure With Rescue Vitrectomy | 8 weeks | — |
Countries
United States
Participant flow
Recruitment details
One eye that did not have full-thickness macular hole was enrolled, received PVL, and completed the 24-week visit but is not included in any analyses or subsequent levels in the participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pneumatic Vitreolysis (PVL) Pneumatic vitreolysis is an in-office intraocular injection of an expansile gas (C3F8) to induce release of vitreomacular traction. | 35 |
| Total | 35 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Pneumatic Vitreolysis (PVL) |
|---|---|
| Age, Continuous | 69 years STANDARD_DEVIATION 9 |
| Diabetes Type No | 27 Participants |
| Diabetes Type Type 2 | 8 Participants |
| E-ETDRS visual acuity letter score | 55.8 units on a scale STANDARD_DEVIATION 14 |
| Epiretinal membrane in central subfield | 1 Eyes |
| Intraocular pressure | 16 mmHg STANDARD_DEVIATION 3 |
| Lens Status on Clinical Exam Phakic (natural lens) | 28 Eyes |
| Lens Status on Clinical Exam Prosthetic intraocular lens | 7 Eyes |
| Loss of ellipsoid zone integrity in central subfield | 35 Eyes |
| Loss of ellipsoid zone integrity in foveal center | 35 Eyes |
| Macular hole width at narrowest point | 79 micron |
| Race/Ethnicity, Customized Hispanic or Latino | 5 Participants |
| Race/Ethnicity, Customized non-Hispanic Black/African American | 3 Participants |
| Race/Ethnicity, Customized Non-Hispanic White | 27 Participants |
| Sex: Female, Male Female | 24 Participants |
| Sex: Female, Male Male | 11 Participants |
| Width of vitreomacular attachment that extends within the central subfield | 325 Microns |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 35 |
| other Total, other adverse events | 15 / 35 |
| serious Total, serious adverse events | 5 / 35 |
Outcome results
Primary
Proportion of Eyes With Macular Hole Closure of Inner Retinal Layers Without Rescue Vitrectomy
Time frame: at 8 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pneumatic Vitreolysis (PVL) | Proportion of Eyes With Macular Hole Closure of Inner Retinal Layers Without Rescue Vitrectomy | 10 Eyes |
Secondary
E-ETDRS Visual Acuity Letter Score
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.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pneumatic Vitreolysis (PVL) | E-ETDRS Visual Acuity Letter Score | 54.2 units on a scale | Standard Deviation 23.8 |
Secondary
Macular Hole Closure Without Rescue Vitrectomy
Time frame: 8 Weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pneumatic Vitreolysis (PVL) | Macular Hole Closure Without Rescue Vitrectomy | 10 Eyes |
Secondary
Macular Hole Closure With Rescue Vitrectomy
Time frame: 8 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pneumatic Vitreolysis (PVL) | Macular Hole Closure With Rescue Vitrectomy | 10 Eyes |
Secondary
Mean Change in E-ETDRS Visual Acuity Letter Score From Baseline
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.
Time frame: Baseline to 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pneumatic Vitreolysis (PVL) | Mean Change in E-ETDRS Visual Acuity Letter Score From Baseline | -1.5 units on a scale | Standard Deviation 25.6 |
Secondary
No Macular Hole Closure and no Rescue Vitrectomy
Time frame: 8 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pneumatic Vitreolysis (PVL) | No Macular Hole Closure and no Rescue Vitrectomy | 13 Eyes |
Secondary
No Macular Hole Closure Despite Rescue Vitrectomy
Time frame: 8 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pneumatic Vitreolysis (PVL) | No Macular Hole Closure Despite Rescue Vitrectomy | 2 Eyes |
Secondary
Number of Eyes With Rescue Treatment Before the 8-week Visit
Time frame: up to 8 Weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pneumatic Vitreolysis (PVL) | Number of Eyes With Rescue Treatment Before the 8-week Visit | 12 Eyes |