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| Name | Class |
|---|---|
| Bascom Palmer Eye Institute | OTHER |
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This is a randomized controlled study of non-damaging photothermal macular grid laser versus sham laser therapy in patients with dry age-related macular degeneration (AMD) and large high-risk drusen. The goal of the study is to determine if this treatment will reduce macular drusen volume and also whether this might improve visual acuity or reduce the risk of conversion to advanced age-related macular degeneration defined as development of choroidal neovascularization or geographic atrophy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laser Arm | Experimental | Participants receive treatment with sub-threshold macular laser photocoagulation |
|
| Sham Laser Arm | Sham Comparator | Participants receive sham treatment with sub-threshold macular laser photocoagulation (with power setting at zero) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pascal Retinal Laser Photocoagulator | Device | Sub-threshold macular laser treatment with Pascal laser Endpoint Management System |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Macular Drusen Volume | Mean change in macular drusen volume as measured on high-resolution spectral domain ocular coherence tomography (SD-OCT) | baseline, 6, 12, and 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Visual Acuity | Mean change in best-corrected visual acuity as measured using early treatment diabetic retinopathy study (ETDRS) chart - average number of letters seen on chart | baseline, 6, 12, and 24 months |
| Development of Geographic Atrophy (GA) or Choroidal Neovascularization (CNV) |
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Inclusion Criteria
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven Sanislo, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Byers Eye Institute at Stanford University | Palo Alto | California | 94303 | United States |
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19 participants signed informed consent; 2 participants failed screening, and 17 participants started the study. Participants may have contributed one or both eyes to the study. If both eyes were enrolled the first eye would be randomly assigned to treatment or sham, and the fellow eye would be assigned to the opposite treatment arm. Participants who contributed more than one eye are counted in more than one reporting group.
Participants recruited from January 2016 until May 2018, at which time interim analysis revealed futility.
| ID | Title | Description |
|---|---|---|
| FG000 | Sub-threshold Macular Laser Photocoagulation | Participants that receive treatment with sub-threshold macular laser photocoagulation |
| FG001 | Sham Laser | Participants that receive sham treatment with sub-threshold macular laser photocoagulation (with power setting at zero) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Randomized participants
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | Participants receive sub-threshold macular laser photocoagulation and/or sham treatment with power setting at zero |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Change in Macular Drusen Volume | Mean change in macular drusen volume as measured on high-resolution spectral domain ocular coherence tomography (SD-OCT) | Participants who contributed more than one eye are counted in more than one reporting group. Data for the participant who did not complete the study are included using the Last Observation Carried Forward (LOCF) method. | Posted | Median | Inter-Quartile Range | mm^3 | baseline, 6, 12, and 24 months | Eyes | Eyes |
|
24 months
Per protocol, only adverse events related to treatment were collected. Participants who contributed more than one eye are counted in more than one reporting group.
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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 | Sub-threshold Macular Laser Photocoagulation | Participants that receive treatment with sub-threshold macular laser photocoagulation |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| mild supra-threshold laser burns | Eye disorders | Systematic Assessment | Laser burns in this study were to be sub-threshold (non-visible). |
This study did not meet enrollment goal of 60 study eyes.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Steven Sanislo, MD | Stanford University School of Medicine | 650-723-6995 | ssanislo@stanford.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 15, 2018 | Feb 24, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D015593 | Retinal Drusen |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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Count of eyes that develop geographic atrophy or choroidal neovascularization by 24 months. |
| 2 years |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| Secondary | Change in Visual Acuity | Mean change in best-corrected visual acuity as measured using early treatment diabetic retinopathy study (ETDRS) chart - average number of letters seen on chart | Participants who contributed more than one eye are counted in more than one reporting group. Data for the participant who did not complete the study are included using the Last Observation Carried Forward (LOCF) method. | Posted | Mean | Standard Deviation | Letters | baseline, 6, 12, and 24 months | Eyes | Eyes |
|
|
|
| Secondary | Development of Geographic Atrophy (GA) or Choroidal Neovascularization (CNV) | Count of eyes that develop geographic atrophy or choroidal neovascularization by 24 months. | Participants who contributed more than one eye are counted in more than one reporting group. Data for the participant who did not complete the study are included using the Last Observation Carried Forward (LOCF) method. | Posted | Count of Units | Eyes | 2 years | Eyes | Eyes |
|
|
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| 0 |
| 10 |
| 0 |
| 10 |
| 1 |
| 10 |
| EG001 | Sham Laser | Participants that receive sham treatment with sub-threshold macular laser photocoagulation (with power setting at zero) | 0 | 9 | 0 | 9 | 0 | 9 |
|
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| 12 month change |
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| 24 month change |
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