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| Name | Class |
|---|---|
| IRIDEX Corporation | UNKNOWN |
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Diabetic retinopathy is one of the most common complications of diabetes and diabetic macular edema (DME) is one of the most common causes of vision loss in diabetes.
The purpose of this study is to determine if early intervention with micropulse laser treatment in eyes with good visual acuity (20/32 or better) will improve or stabilize vision loss due to the complications of diabetic macular edema.
This is a randomized, controlled clinical trial comparing subthreshold micropulse laser versus sham laser treatment for eyes with diabetic macular edema with good visual acuity of 20/32 or better.
Subjects will be randomized to receive either subthreshold micropulse laser treatment or no treatment (sham). Randomization will occur as a ratio of 2:1 and will take place during the clinic visit.
Subjects selected for the study will undergo a complete ophthalmic examination, including measurements of best corrected visual acuity, low luminance visual acuity, contrast sensitivity (using ETDRS testing with a masked coordinator), intraocular pressure, slit lamp exam including documentation of lens status, and dilated funduscopic exam with standard dilating agents used at the UC Davis Eye Center. Subjects will then undergo baseline imaging including Spectral Domain Ocular Coherence Tomography (SD-OCT), fundus autofluorescence (FAF) and microperimetry testing. Both the use of OCT, FAF, and microperimetry testing are within the standard of care for the management of DME.
The duration of an individual subject's participation in the study will be two years which will include at least 10 total visits at various time points including on the day of enrollment, followed by 1, 3, 6, 9, and 12, 15, 18, 21, 24 months after the day of enrollment.
The subjects in the treatment arm will be treated on the day of randomization by SML photocoagulation using the Iridex IQ577 laser unit with TxCell scanning laser delivery system.
Subjects in the sham treatment arm will undergo the same set up procedures as those receiving the laser treatment, however, no actual laser treatment will occur.
Subjects will then return to the clinic for repeat ophthalmic exam, OCT imaging, and microperimetry at 1 month, 3 month, 6 month, 9 month, 12 month, 15 month, 18 month, 21 month and 24 month time points, which is similar in frequency as standard of care.
Patients in the treatment arm are eligible for repeat SML laser at any subsequent visit if there is any decline in vision (1 or more ETDRS lines) or worsening in edema (>10% increase), at the discretion of the treating physician. If vision declines to 20/40 or worse at any study visit, patients in the treatment arm will undergo repeat treatment with SML laser, while those in the sham arm will undergo repeat sham laser.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Micropulse Laser Treatment | Active Comparator | Subjects assigned to the micropulse laser arm of the trial will undergo the following procedures:
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| Sham Treatment | Placebo Comparator | Subjects assigned to the sham arm of the trial will undergo the following procedures:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Micropulse Laser Treatment | Device | Participant's study eye will be dilated prior to being comfortably seated at the slit lamp for treatment. Application of micropulse laser on retinal surface will occur using TxCell Scanning Delivery System in a 7 x 7 grid to surround the fovea. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects With Vision Loss to 20/40 or Worse | BCVA measured using ETDRS testing. The study endpoint was reached if the study patient experienced vision loss of ≥10 letters (≥2 lines) at any visit or 5-9 letters (1-2 lines) at 2 consecutive visits ≤28 days apart, based on the criteria for initiating anti-VEGF therapy as defined in the DRCR Protocol V study. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Acuity at 6 Month | Visual acuity measured using ETDRS | 6 months |
| Low Luminance Visual Acuity at 6 Months | Low Luminance Visual acuity measured with a 2.0-log unit neutral density filter |
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Inclusion Criteria:
Age >=18 years
Type 1 or type 2 diabetes mellitus
Clinical evidence of center-involved DME confirmed on OCT, and defined by OCT
Central Subfield (CSF) thickness at the time of randomization by the following:
Best corrected visual acuity of 20/32 or better on ETDRS testing
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Glenn Yiu, MD, PhD | University of California, Davis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Davis | Sacramento | California | 95817 | United States |
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| Label | URL |
|---|---|
| Learn more or sign up for the study here! | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Micropulse Laser Treatment | Eyes assigned to the micropulse laser arm of the trial will undergo the following procedures:
Micropulse Laser Treatment: Participant's study eye will be dilated prior to being comfortably seated at the slit lamp for treatment. Application of micropulse laser on retinal surface will occur using TxCell Scanning Delivery System in a 7 x 7 grid to surround the fovea. |
| FG001 | Sham Treatment | Eyes assigned to the sham arm of the trial will undergo the following procedures:
Sham Treatment: Participant's study eye will be dilated prior to being comfortably seated at the slit lamp for treatment. No actual laser treatment will occur. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Sex: male, female
| ID | Title | Description |
|---|---|---|
| BG000 | Micropulse Laser Treatment | Subjects assigned to the micropulse laser arm of the trial will undergo the following procedures:
Micropulse Laser Treatment: Participant's study eye will be dilated prior to being comfortably seated at the slit lamp for treatment. Application of micropulse laser on retinal surface will occur using TxCell Scanning Delivery System in a 7 x 7 grid to surround the fovea. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 19 participants were enrolled. Of those 19 participants, 11 had only one eye enrolled. This accounts for the row population difference. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Subjects With Vision Loss to 20/40 or Worse | BCVA measured using ETDRS testing. The study endpoint was reached if the study patient experienced vision loss of ≥10 letters (≥2 lines) at any visit or 5-9 letters (1-2 lines) at 2 consecutive visits ≤28 days apart, based on the criteria for initiating anti-VEGF therapy as defined in the DRCR Protocol V study. | Posted | Count of Units | Eyes | 6 months | Eyes | Eyes |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Micropulse Laser Treatment | Eyes assigned to the micropulse laser arm of the trial will undergo the following procedures:
Micropulse Laser Treatment: Participant's study eye will be dilated prior to being comfortably seated at the slit lamp for treatment. Application of micropulse laser on retinal surface will occur using TxCell Scanning Delivery System in a 7 x 7 grid to surround the fovea. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Worsening Diabetic Macular Edema | Eye disorders | MedDRA (10.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Research Supervisor | University of California, Davis Eye Center | 916 734-6303 | dcmacias@ucdavis.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 6, 2021 | Jul 11, 2024 | Prot_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 10, 2021 | Jun 7, 2024 | ICF_001.pdf |
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Subjects will be masked to their treatment assignment. The research coordinator that performs the measurement of best corrected visual acuity will be masked to the treatment assignment. The reading center analyst responsible for reviewing and analyzing OCT and microperimetry reports will be masked to treatment assignment.
|
| Sham Treatment | Device | Participant's study eye will be dilated prior to being comfortably seated at the slit lamp for treatment. No actual laser treatment will occur. |
|
| 6 months |
| Contrast Sensitivity at 6 Months | Contrast sensitivity is measured using a single, large letter size (20/60 optotype) with contrast varying across groups of letters. The contrast sensitivity chart (CS) uses letters whose contrast varies from high to low. The scale is 0.0 (minimum) to 2.0 (maximum). A higher score equates to a better outcome. The score is based on the contrast of the last group in which 2 or 3 letters were correctly read. A score of 2.0 indicates normal CS of 100%. Scores < than 2.0 signify poorer CS; scores < than 1.5 is consistent with visual impairment; a score < than 1.0 represents visual disability. | 6 months |
| Central Subfield Thickness (CST) at 6 Months | Using Heidelberg Spectralis device to measure central subfield thickness (CST) | 6 months |
| Microperimetry Average Threshold at 6 Month | Performed using the Macular Integrity Assessment (MAIA) Instrument | 6 months |
| Withdrawal by Subject |
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| Change to insurance |
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| Other |
|
| BG001 | Sham Treatment | Subjects assigned to the sham arm of the trial will undergo the following procedures:
Sham Treatment: Participant's study eye will be dilated prior to being comfortably seated at the slit lamp for treatment. No actual laser treatment will occur. |
| BG002 | Total | Total of all reporting groups |
| Eyes |
|
| Mean |
| Standard Deviation |
| Years |
| Eyes |
|
| Sex: Female, Male | Count of Units | Eyes | Eyes |
|
| Race (NIH/OMB) | Count of Units | Eyes | Eyes |
|
| Best Corrected Visual Acuity (BCVA) | Mean | Standard Deviation | ETDRS Letters Read | Eyes |
|
| Low Luminance Visual Acuity (LLVA) | Mean | Standard Deviation | EDTDRS Letters Read | Eyes |
|
| Contrast Sensitivity (CS) | The contrast sensitivity chart (CS) uses letters whose contrast varies from high to low. The scale is 0.0 (minimum) to 2.0 (maximum). A higher score equates to a better outcome. The score is based on the contrast of the last group in which 2 or 3 letters were correctly read. A score of 2.0 indicates normal CS of 100%. Scores < than 2.0 signify poorer CS; scores < than 1.5 is consistent with visual impairment; a score < than 1.0 represents visual disability. | Mean | Standard Deviation | unit less | Eyes |
|
| Central Subfield Thickness (CST) | Mean | Standard Deviation | microns | Eyes |
|
| Microperimetry Average Threshold | Mean | Standard Deviation | decibels (dB) | Eyes |
|
| OG001 | Sham Treatment | Eyes assigned to the sham arm of the trial will undergo the following procedures:
Sham Treatment: Participant's study eye will be dilated prior to being comfortably seated at the slit lamp for treatment. No actual laser treatment will occur. |
|
|
|
| Secondary | Visual Acuity at 6 Month | Visual acuity measured using ETDRS | Posted | Mean | Standard Deviation | Letters Read | 6 months | Eyes | Eyes |
|
|
|
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| Secondary | Low Luminance Visual Acuity at 6 Months | Low Luminance Visual acuity measured with a 2.0-log unit neutral density filter | Posted | Mean | Standard Deviation | Letters Read | 6 months | Eyes | Eyes |
|
|
|
|
| Secondary | Contrast Sensitivity at 6 Months | Contrast sensitivity is measured using a single, large letter size (20/60 optotype) with contrast varying across groups of letters. The contrast sensitivity chart (CS) uses letters whose contrast varies from high to low. The scale is 0.0 (minimum) to 2.0 (maximum). A higher score equates to a better outcome. The score is based on the contrast of the last group in which 2 or 3 letters were correctly read. A score of 2.0 indicates normal CS of 100%. Scores < than 2.0 signify poorer CS; scores < than 1.5 is consistent with visual impairment; a score < than 1.0 represents visual disability. | Posted | Mean | Standard Deviation | unit less | 6 months | Eyes | Eyes |
|
|
|
|
| Secondary | Central Subfield Thickness (CST) at 6 Months | Using Heidelberg Spectralis device to measure central subfield thickness (CST) | Posted | Mean | Standard Deviation | microns | 6 months | Eyes | Eyes |
|
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|
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| Secondary | Microperimetry Average Threshold at 6 Month | Performed using the Macular Integrity Assessment (MAIA) Instrument | Posted | Mean | Standard Deviation | dB | 6 months | Eyes | Eyes |
|
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|
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| 0 |
| 16 |
| 0 |
| 16 |
| 5 |
| 16 |
| EG001 | Sham Treatment | Eyes assigned to the sham arm of the trial will undergo the following procedures:
Sham Treatment: Participant's study eye will be dilated prior to being comfortably seated at the slit lamp for treatment. No actual laser treatment will occur. | 0 | 11 | 0 | 11 | 2 | 11 |
| Vitreous Hemorrhage | Eye disorders | MedDRA (10.0) | Systematic Assessment |
|
| Posterior Vitreous Detachment | Eye disorders | MedDRA (10.0) | Systematic Assessment |
|
| Decrease in Visual Acuity | Eye disorders | MedDRA (10.0) | Systematic Assessment |
|
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