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| ID | Type | Description | Link |
|---|---|---|---|
| 1UG1EY026876-01A1 | U.S. NIH Grant/Contract | View source | |
| 1UG1EY028517-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Eye Institute (NEI) | NIH |
| University of California, Davis | OTHER |
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This study evaluates whether intravitreal autologous CD34+ stem cell therapy is safe, feasible and potentially beneficial in eyes with vision loss from central retinal vein occlusion (CRVO). Half of the participants will receive immediate cellular therapy followed by sham therapy 6 months later, while the other half will receive immediate sham therapy followed by cellular therapy 6 months later. Participants will be followed for a total of 1 year.
The goal of this phase I/II prospective, randomized, sham-controlled, double-masked clinical trial is to determine whether intravitreal autologous CD34+ stem cell therapy is safe, feasible and potentially beneficial in eyes with vision loss from central retinal vein occlusion (CRVO). Retinal Vein Occlusion (RVO) is a leading retinal vascular cause of vision loss in the elderly. CD34+ stem cells in human bone marrow are mobilized into the circulation in response to tissue ischemia for tissue revascularization and repair. Since local delivery of CD34+ stem cells benefits ischemic tissue, intravitreal delivery of CD34+ stem cells may benefit vision and retinal ischemia in eyes with RVO. A pilot clinical trial has shown no major safety or feasibility concerns using intravitreal autologous CD34+ bone marrow stem cells. In this proposed expanded phase I/II study, 20 participants (20 eyes) with persistent vision loss from CRVO will be enrolled and followed for 1 year.
Participants will be randomized 1:1 to immediate cell therapy/deferred sham therapy or immediate sham therapy/deferred cell therapy. At month 6, the cell treated eye will receive sham treatment and the sham treated eye will get cell therapy. The cellular therapy involves bone marrow aspiration, isolation of CD34+ cells from the aspirate under Good Manufacturing Practice (GMP) conditions, and intravitreal injection of isolated CD34+ cells. The sham therapy involves a sham bone marrow aspiration with penetration of the skin but no penetration of the bone and a sham intravitreal injection without penetrating the eye. The participant, examining ophthalmologist, visual acuity examiner, photographers and OCT, perimetry, and electroretinography (ERG) technicians will remain masked to study treatment assignment for study duration. A comprehensive eye examination with ETDRS best-corrected visual acuity, optical coherence tomography (OCT) and OCT angiography (OCTA), autofluorescence, fundus photography, fluorescein angiography, microperimetry, and electroretinography will be performed at baseline and serially. A subset of participants with good fixation on microperimetry and clear media on exam and commercial-grade OCTA and who give consent will have ultra-high resolution cellular retinal imaging using research-grade OCT and OCTA and adaptive optics-OCT at baseline. Participants with high quality images will have repeat imaging at 1 month after stem cell treatment, with at least 2 of the participants randomized to the deferred cellular therapy arm also having imaging 1 month after sham therapy. Post-release flow cytometry characterization will be performed to determine the composition of the CD34+ enriched final product in terms of hematopoietic versus angiogenic stem cells based on cell surface markers (i.e., CD133(+)/CD45(+)/CD34(+) vs CD31(+)/VEGFR-2(+)/CD45(-)/CD34(+)). The long-term objective is to determine whether intravitreal autologous CD34+ cell therapy can minimize, or reverse vision loss associated with retinal ischemia without compromising safety.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate Cellular Therapy / Deferred Sham Therapy | Active Comparator | At baseline: Bone marrow aspiration followed by intravitreal injection of CD34+ cells. At 6 months: Sham bone marrow aspiration and sham intravitreal injection. |
|
| Immediate Sham Therapy / Deferred Cellular Therapy | Sham Comparator | At baseline: Sham bone marrow aspiration followed by sham intravitreal injection. At 6 months: Bone marrow aspiration followed by intravitreal injection of CD34+ cells. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous Bone Marrow CD34+ Stem Cells | Biological | Single intravitreal injection of autologous bone marrow CD34+ stem cells. The number of cells to be injected per eye will range from 800,000 to 10 million, depending on the yield of the bone marrow aspiration and the isolation procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and Severity of Ocular and Systemic Adverse Events | The primary safety outcome will be assessed at month 6. Adverse events (AE) that occur during the first 6 months of the trial will be broken down by whether the AE occurred following the sham or cellular treatment to assess differences in the adverse event experience between the cellular and sham therapies. | Months 0 to 6 |
| Feasibility of the Stem Cell Therapy | Number of CD34+ cells isolated from the bone marrow aspirate and number of cells injected into the eye | Day 0 and Day 182 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity Letter Score | Mean change from baseline of visual acuity letter score at Month 6. The measure is calculated by subtracting the baseline visual acuity letter score from the month 6 visual acuity letter score. The participant is refracted for best corrected vision, and then reads single letters from the ETDRS charts using a visual acuity light box at a 4 meter distance (or 1 meter for participants with sufficiently reduced vision) according to a specific algorithm. A letter score is provided that ranges from 0 (unable to read any letters) to 100. A visual acuity letter score of 85 corresponds to a visual acuity of 20/20 as a Snellen equivalent. Higher is better. |
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Study Eye Inclusion/Exclusion Criteria:
Inclusion criteria for the study eye:
Exclusion criteria for the study eye:
Participant-level Inclusion/Exclusion Criteria:
Participant-level inclusion criteria:
Participant-level exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susanna S Park, MD, PhD | University of California, Davis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Ophthalmology & Vision Science, University of California Davis Eye Center | Sacramento | California | 95817 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25491299 | Background | Park SS, Bauer G, Abedi M, Pontow S, Panorgias A, Jonnal R, Zawadzki RJ, Werner JS, Nolta J. Intravitreal autologous bone marrow CD34+ cell therapy for ischemic and degenerative retinal disorders: preliminary phase 1 clinical trial findings. Invest Ophthalmol Vis Sci. 2014 Dec 9;56(1):81-9. doi: 10.1167/iovs.14-15415. | |
| 39328826 | Background | Park SS, Bauer G, Fury B, Abedi M, Perotti N, Colead-Bergum D, Nolta JA. Phase I Study of Intravitreal Injection of Autologous CD34+ Stem Cells from Bone Marrow in Eyes with Vision Loss from Retinitis Pigmentosa. Ophthalmol Sci. 2024 Jul 31;5(1):100589. doi: 10.1016/j.xops.2024.100589. eCollection 2025 Jan-Feb. |
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TRUST will follow specific plans for sharing of research data under the guidance of NIH's 2003 Data Sharing Policy. After analysis, the final data set can be provided after appropriate procedures are implemented to preserve the anonymity of the records, specifically where protected health information (PHI) is required. Upon request, anonymized data will be shared under confidentiality agreements with researchers interested in the project.
Time Frame will be determined.
Confidentiality agreements will be required before anonymized data will be shared.
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| ID | Title | Description |
|---|---|---|
| FG000 | Immediate Cellular Therapy / Deferred Sham Therapy | At baseline: Bone marrow aspiration followed by intravitreal injection of CD34+ cells. At 6 months: Sham bone marrow aspiration and sham intravitreal injection. Autologous Bone Marrow CD34+ Stem Cells: Single intravitreal injection of autologous bone marrow CD34+ stem cells. The number of cells to be injected per eye will range from 800,000 to 10 million, depending on the yield of the bone marrow aspiration and the isolation procedure. Sham Therapy: Sham bone marrow aspiration procedure that penetrates the skin, but does not penetrate the bone followed by sham intravitreal injection without penetration of the eye |
| FG001 | Immediate Sham Therapy / Deferred Cellular Therapy | At baseline: Sham bone marrow aspiration followed by sham intravitreal injection. At 6 months: Bone marrow aspiration followed by intravitreal injection of CD34+ cells. Autologous Bone Marrow CD34+ Stem Cells: Single intravitreal injection of autologous bone marrow CD34+ stem cells. The number of cells to be injected per eye will range from 800,000 to 10 million, depending on the yield of the bone marrow aspiration and the isolation procedure. Sham Therapy: Sham bone marrow aspiration procedure that penetrates the skin, but does not penetrate the bone followed by sham intravitreal injection without penetration of the eye |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Immediate Cellular Therapy / Deferred Sham Therapy | At baseline: Bone marrow aspiration followed by intravitreal injection of CD34+ cells. At 6 months: Sham bone marrow aspiration and sham intravitreal injection. Autologous Bone Marrow CD34+ Stem Cells: Single intravitreal injection of autologous bone marrow CD34+ stem cells. The number of cells to be injected per eye will range from 800,000 to 10 million, depending on the yield of the bone marrow aspiration and the isolation procedure. Sham Therapy: Sham bone marrow aspiration procedure that penetrates the skin, but does not penetrate the bone followed by sham intravitreal injection without penetration of the eye |
| 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 | Incidence and Severity of Ocular and Systemic Adverse Events | The primary safety outcome will be assessed at month 6. Adverse events (AE) that occur during the first 6 months of the trial will be broken down by whether the AE occurred following the sham or cellular treatment to assess differences in the adverse event experience between the cellular and sham therapies. | Number of participants randomized | Posted | Number | participants | Months 0 to 6 |
|
Baseline to Month 12
The safety of the intravitreal injection of autologous CD34+ cells was assessed through regular eye examinations during the 12 month follow-up period. Adverse events (AEs) including new or worsening ocular conditions that occured from the time the participant signed informed consent until the final study visit were recorded, regardless of suspected cause. An AE and/or serious adverse event form was completed and the information was entered into the study electronic data capture system.
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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 | Immediate Cellular Therapy / Deferred Sham Therapy: Months 0-6 | Data for Month 0 through Month 6. Treatment arms defined as follows. At baseline: Bone marrow aspiration followed by intravitreal injection of CD34+ cells. At 6 months: Sham bone marrow aspiration and sham intravitreal injection. Autologous Bone Marrow CD34+ Stem Cells: Single intravitreal injection of autologous bone marrow CD34+ stem cells. The number of cells to be injected per eye will range from 800,000 to 10 million, depending on the yield of the bone marrow aspiration and the isolation procedure. Sham Therapy: Sham bone marrow aspiration procedure that penetrates the skin, but does not penetrate the bone followed by sham intravitreal injection without penetration of the eye |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Appendicitis | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (26.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Principal Investigator of the TRUST Data Coordinating Center | The Emmes Company, LLC | 301-251-1161 | trust@emmes.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 22, 2023 | Oct 30, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 2, 2024 | Nov 1, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D012170 | Retinal Vein Occlusion |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| ID | Term |
|---|---|
| D020246 | Venous Thrombosis |
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
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The participant, examining ophthalmologist, visual acuity examiner, photographers and OCT, perimetry, and ERG technicians will remain masked to study treatment assignment for study duration.
|
| Sham Therapy | Biological | Sham bone marrow aspiration procedure that penetrates the skin, but does not penetrate the bone followed by sham intravitreal injection without penetration of the eye |
|
| Months 0 to 6 |
| Change in % Reduced Sensitivity | Mean change from baseline of % reduced sensitivity at Month 6 as measured by microperimetry (decrease is better) | Months 0 to 6 |
| Change in Average Threshold | Mean change from baseline of average threshold (dB) at Month 6 as measured by microperimetry (increase is better) | Months 0 to 6 |
| Change in Percent Normal Amplitude for ERG+OP (Oscillatory Potential) A-wave Under Scotopic Conditions | Mean change from baseline of percent of normal amplitude for ERG+OP a-wave under scotopic conditions at Month 6 as measured by Full-field ERG (increase is better) | Months 0 to 6 |
| Change in Percent Normal Amplitude for ERG+OP B-wave Under Scotopic Conditions | Mean change from baseline of percent of normal amplitude for ERG+OP b-wave under scotopic conditions at Month 6 as measured by Full-field ERG (increase is better) | Months 0 to 6 |
| Change in Percent Normal Latency of ERG+OP A-wave Under Scotopic Conditions | Mean change from baseline of percent normal latency of ERG+OP a-wave under scotopic conditions at Month 6 as measured by Full-field ERG (decrease is better) | Months 0 to 6 |
| Change in Percent Normal Latency of ERG+OP B-wave Under Scotopic Conditions | Mean change from baseline of percent normal latency of ERG+OP b-wave under scotopic conditions at Month 6 as measured by Full-field ERG (decrease is better) | Months 0 to 6 |
| Change in Percent Normal Amplitude for A-wave Under Photopic Conditions | Mean change from baseline of percent normal amplitude for a-wave under photopic conditions at Month 6 as measured by Full-field ERG (increase is better) | Months 0 to 6 |
| Change in Percent Normal Amplitude for B-wave Under Photopic Conditions | Mean change from baseline of percent normal amplitude for b-wave under photopic conditions at Month 6 as measured by Full-field ERG (increase is better) | Months 0 to 6 |
| Change in Percent Normal Latency for A-wave Under Photopic Conditions | Mean change from baseline of percent normal latency for a-wave under photopic conditions at Month 6 as measured by Full-field ERG (decrease is better) | Months 0 to 6 |
| Change in Percent Normal Latency for B-wave Under Photopic Conditions | Mean change from baseline of percent normal latency for b-wave under photopic conditions at Month 6 as measured by Full-field ERG (decrease is better) | Months 0 to 6 |
| Change in Percent Normal Flicker Amplitude | Mean change from baseline in percent normal flicker amplitude at Month 6 as measured by Full-field ERG (increase is better) | Months 0 to 6 |
| Change in Flicker Latency Trough | Mean change from baseline of latency trough at Month 6 as measured by Full-field ERG (decrease is better) | Months 0 to 6 |
| Change in Percent Normal Amplitude for A-wave Under Scotopic Conditions | Mean change from baseline of percent normal amplitude for a-wave under scotopic conditions at Month 6 as measured by Full-field ERG (increase is better) | Months 0 to 6 |
| Change in Percent Normal Latency of A-wave Under Scotopic Conditions | Mean change from baseline of percent normal latency of a-wave under scotopic conditions at Month 6 as measured by Full-field ERG (decrease is better) | Months 0 to 6 |
| Change in Percent Normal Amplitude for B-wave Under Scotopic Conditions | Mean change from baseline of percent normal amplitude for b-wave under scotopic conditions at Month 6 as measured by Full-field ERG (increase is better) | Months 0 to 6 |
| Change in Percent Normal Latency for B-wave Under Scotopic Conditions | Mean change from baseline of percent normal latency for b-wave under scotopic conditions at Month 6 as measured by Full-field ERG (decrease is better) | Months 0 to 6 |
| Foveal Avascular Zone Integrity | Number of study eyes in each of the following categories as it relates to the integrity of the foveal avascular zone: Intact, Questionable, Disrupted (<900 microns), Disrupted (900-1800 microns), Disrupted (>1800 microns), and Cannot grade. Measured at Month 6 by fluorescein angiogram | 6 months |
| Change in Area of Non-perfusion Within ETDRS Grid | Mean change from baseline of area of non-perfusion within ETDRS grid at Month 6 as measured by fluorescein angiogram (decrease is better) | Months 0 to 6 |
| Change in Area of Non-perfusion Within Networc Grid | Mean change from baseline of area of non-perfusion within Networc grid at Month 6 as measured by fluorescein angiogram (decrease is better) | Months 0 to 6 |
| 36912792 | Derived | Romano F, Lamanna F, Gabrielle PH, Teo KYC, Battaglia Parodi M, Iacono P, Fraser-Bell S, Cornish EE, Nassisi M, Viola F, Agarwal A, Samanta A, Chhablani J, Staurenghi G, Invernizzi A. Update on Retinal Vein Occlusion. Asia Pac J Ophthalmol (Phila). 2023 Mar-Apr 01;12(2):196-210. doi: 10.1097/APO.0000000000000598. Epub 2023 Feb 14. |
| BG001 | Immediate Sham Therapy / Deferred Cellular Therapy | At baseline: Sham bone marrow aspiration followed by sham intravitreal injection. At 6 months: Bone marrow aspiration followed by intravitreal injection of CD34+ cells. Autologous Bone Marrow CD34+ Stem Cells: Single intravitreal injection of autologous bone marrow CD34+ stem cells. The number of cells to be injected per eye will range from 800,000 to 10 million, depending on the yield of the bone marrow aspiration and the isolation procedure. Sham Therapy: Sham bone marrow aspiration procedure that penetrates the skin, but does not penetrate the bone followed by sham intravitreal injection without penetration of the eye |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | Immediate Sham Therapy / Deferred Cellular Therapy | At baseline: Sham bone marrow aspiration followed by sham intravitreal injection. At 6 months: Bone marrow aspiration followed by intravitreal injection of CD34+ cells. Autologous Bone Marrow CD34+ Stem Cells: Single intravitreal injection of autologous bone marrow CD34+ stem cells. The number of cells to be injected per eye will range from 800,000 to 10 million, depending on the yield of the bone marrow aspiration and the isolation procedure. Sham Therapy: Sham bone marrow aspiration procedure that penetrates the skin, but does not penetrate the bone followed by sham intravitreal injection without penetration of the eye |
|
|
| Primary | Feasibility of the Stem Cell Therapy | Number of CD34+ cells isolated from the bone marrow aspirate and number of cells injected into the eye | All participants with successful bone marrow aspiration | Posted | Mean | Standard Deviation | Number of cells in millions | Day 0 and Day 182 |
|
|
|
| Secondary | Change in Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity Letter Score | Mean change from baseline of visual acuity letter score at Month 6. The measure is calculated by subtracting the baseline visual acuity letter score from the month 6 visual acuity letter score. The participant is refracted for best corrected vision, and then reads single letters from the ETDRS charts using a visual acuity light box at a 4 meter distance (or 1 meter for participants with sufficiently reduced vision) according to a specific algorithm. A letter score is provided that ranges from 0 (unable to read any letters) to 100. A visual acuity letter score of 85 corresponds to a visual acuity of 20/20 as a Snellen equivalent. Higher is better. | All participants with visual acuity letter score recorded at Month 6 | Posted | Mean | Standard Deviation | Letters read | Months 0 to 6 |
|
|
|
| Secondary | Change in % Reduced Sensitivity | Mean change from baseline of % reduced sensitivity at Month 6 as measured by microperimetry (decrease is better) | All participants with reduced sensitivity recorded at Month 6 | Posted | Mean | Standard Deviation | percent reduced | Months 0 to 6 |
|
|
|
| Secondary | Change in Average Threshold | Mean change from baseline of average threshold (dB) at Month 6 as measured by microperimetry (increase is better) | All participants with average threshold recorded at Month 6 | Posted | Mean | Standard Deviation | dB | Months 0 to 6 |
|
|
|
| Secondary | Change in Percent Normal Amplitude for ERG+OP (Oscillatory Potential) A-wave Under Scotopic Conditions | Mean change from baseline of percent of normal amplitude for ERG+OP a-wave under scotopic conditions at Month 6 as measured by Full-field ERG (increase is better) | All participants with normal amplitude for ERG+OP a-wave under scotopic conditions recorded at Month 6 | Posted | Mean | Standard Deviation | percent normal amplitude | Months 0 to 6 |
|
|
|
| Secondary | Change in Percent Normal Amplitude for ERG+OP B-wave Under Scotopic Conditions | Mean change from baseline of percent of normal amplitude for ERG+OP b-wave under scotopic conditions at Month 6 as measured by Full-field ERG (increase is better) | All participants with normal amplitude for ERG+OP b-wave under scotopic conditions recorded at Month 6 | Posted | Mean | Standard Deviation | percent normal amplitude | Months 0 to 6 |
|
|
|
| Secondary | Change in Percent Normal Latency of ERG+OP A-wave Under Scotopic Conditions | Mean change from baseline of percent normal latency of ERG+OP a-wave under scotopic conditions at Month 6 as measured by Full-field ERG (decrease is better) | All participants with normal latency for a-wave under scotopic conditions recorded at Month 6 | Posted | Mean | Standard Deviation | percent normal latency | Months 0 to 6 |
|
|
|
| Secondary | Change in Percent Normal Latency of ERG+OP B-wave Under Scotopic Conditions | Mean change from baseline of percent normal latency of ERG+OP b-wave under scotopic conditions at Month 6 as measured by Full-field ERG (decrease is better) | All participants with normal latency of ERG+OP b-wave under scotopic conditions recorded at Month 6 | Posted | Mean | Standard Deviation | percent normal latency | Months 0 to 6 |
|
|
|
| Secondary | Change in Percent Normal Amplitude for A-wave Under Photopic Conditions | Mean change from baseline of percent normal amplitude for a-wave under photopic conditions at Month 6 as measured by Full-field ERG (increase is better) | All participants with normal amplitude for a-wave under photopic conditions recorded at Month 6 | Posted | Mean | Standard Deviation | percent normal amplitude | Months 0 to 6 |
|
|
|
| Secondary | Change in Percent Normal Amplitude for B-wave Under Photopic Conditions | Mean change from baseline of percent normal amplitude for b-wave under photopic conditions at Month 6 as measured by Full-field ERG (increase is better) | All participants with normal amplitude for b-wave under photopic conditions recorded at Month 6 | Posted | Mean | Standard Deviation | percent normal amplitude | Months 0 to 6 |
|
|
|
| Secondary | Change in Percent Normal Latency for A-wave Under Photopic Conditions | Mean change from baseline of percent normal latency for a-wave under photopic conditions at Month 6 as measured by Full-field ERG (decrease is better) | All participants with normal latency for a-wave under photopic conditions recorded at Month 6 | Posted | Mean | Standard Deviation | percent normal latency | Months 0 to 6 |
|
|
|
| Secondary | Change in Percent Normal Latency for B-wave Under Photopic Conditions | Mean change from baseline of percent normal latency for b-wave under photopic conditions at Month 6 as measured by Full-field ERG (decrease is better) | All participants with normal latency for b-wave under photopic conditions recorded at Month 6 | Posted | Mean | Standard Deviation | percent normal latency | Months 0 to 6 |
|
|
|
| Secondary | Change in Percent Normal Flicker Amplitude | Mean change from baseline in percent normal flicker amplitude at Month 6 as measured by Full-field ERG (increase is better) | All participants with normal flicker amplitude recorded at Month 6 | Posted | Mean | Standard Deviation | percent normal flicker amplitude | Months 0 to 6 |
|
|
|
| Secondary | Change in Flicker Latency Trough | Mean change from baseline of latency trough at Month 6 as measured by Full-field ERG (decrease is better) | All participants with latency trough recorded at Month 6 | Posted | Mean | Standard Deviation | percent latency trough | Months 0 to 6 |
|
|
|
| Secondary | Change in Percent Normal Amplitude for A-wave Under Scotopic Conditions | Mean change from baseline of percent normal amplitude for a-wave under scotopic conditions at Month 6 as measured by Full-field ERG (increase is better) | All participants with normal amplitude for a-wave under scotopic conditions recorded at Month 6 | Posted | Mean | Standard Deviation | percent normal amplitude | Months 0 to 6 |
|
|
|
| Secondary | Change in Percent Normal Latency of A-wave Under Scotopic Conditions | Mean change from baseline of percent normal latency of a-wave under scotopic conditions at Month 6 as measured by Full-field ERG (decrease is better) | All participants with normal latency of a-wave under scotopic conditions recorded at Month 6 | Posted | Mean | Standard Deviation | percent normal latency | Months 0 to 6 |
|
|
|
| Secondary | Change in Percent Normal Amplitude for B-wave Under Scotopic Conditions | Mean change from baseline of percent normal amplitude for b-wave under scotopic conditions at Month 6 as measured by Full-field ERG (increase is better) | All participants with normal amplitude for b-wave under scotopic conditions recorded at Month 6 | Posted | Mean | Standard Deviation | percent normal amplitude | Months 0 to 6 |
|
|
|
| Secondary | Change in Percent Normal Latency for B-wave Under Scotopic Conditions | Mean change from baseline of percent normal latency for b-wave under scotopic conditions at Month 6 as measured by Full-field ERG (decrease is better) | All participants with normal latency for b-wave under scotopic conditions recorded at Month 6 | Posted | Mean | Standard Deviation | percent normal latency | Months 0 to 6 |
|
|
|
| Secondary | Foveal Avascular Zone Integrity | Number of study eyes in each of the following categories as it relates to the integrity of the foveal avascular zone: Intact, Questionable, Disrupted (<900 microns), Disrupted (900-1800 microns), Disrupted (>1800 microns), and Cannot grade. Measured at Month 6 by fluorescein angiogram | All participants with integrity of the foveal avascular zone recorded at Month 6 | Posted | Count of Participants | Participants | 6 months |
|
|
|
| Secondary | Change in Area of Non-perfusion Within ETDRS Grid | Mean change from baseline of area of non-perfusion within ETDRS grid at Month 6 as measured by fluorescein angiogram (decrease is better) | All participants with area of non-perfusion within ETDRS grid recorded at Month 6 | Posted | Mean | Standard Deviation | mm^2 | Months 0 to 6 |
|
|
|
| Secondary | Change in Area of Non-perfusion Within Networc Grid | Mean change from baseline of area of non-perfusion within Networc grid at Month 6 as measured by fluorescein angiogram (decrease is better) | All participants with area of non-perfusion within Networc grid recorded at Month 6 | Posted | Mean | Standard Deviation | mm^2 | Months 0 to 6 |
|
|
|
| 0 |
| 7 |
| 0 |
| 7 |
| 7 |
| 7 |
| EG001 | Immediate Sham Therapy / Deferred Cellular Therapy: Months 0-6 | Data for Month 0 through Month 6. Treatment arms defined as follows. At baseline: Sham bone marrow aspiration followed by sham intravitreal injection. At 6 months: Bone marrow aspiration followed by intravitreal injection of CD34+ cells. Autologous Bone Marrow CD34+ Stem Cells: Single intravitreal injection of autologous bone marrow CD34+ stem cells. The number of cells to be injected per eye will range from 800,000 to 10 million, depending on the yield of the bone marrow aspiration and the isolation procedure. Sham Therapy: Sham bone marrow aspiration procedure that penetrates the skin, but does not penetrate the bone followed by sham intravitreal injection without penetration of the eye | 0 | 9 | 1 | 9 | 9 | 9 |
| EG002 | Immediate Cellular Therapy / Deferred Sham Therapy: Months 6-12 | Data for Month 6 through Month 12. Treatment arms defined as follows. At baseline: Bone marrow aspiration followed by intravitreal injection of CD34+ cells. At 6 months: Sham bone marrow aspiration and sham intravitreal injection. Autologous Bone Marrow CD34+ Stem Cells: Single intravitreal injection of autologous bone marrow CD34+ stem cells. The number of cells to be injected per eye will range from 800,000 to 10 million, depending on the yield of the bone marrow aspiration and the isolation procedure. Sham Therapy: Sham bone marrow aspiration procedure that penetrates the skin, but does not penetrate the bone followed by sham intravitreal injection without penetration of the eye | 0 | 7 | 1 | 7 | 7 | 7 |
| EG003 | Immediate Sham Therapy / Deferred Cellular Therapy: Months 6-12 | Data for Month 6 through Month 12. Treatment arms defined as follows. At baseline: Sham bone marrow aspiration followed by sham intravitreal injection. At 6 months: Bone marrow aspiration followed by intravitreal injection of CD34+ cells. Autologous Bone Marrow CD34+ Stem Cells: Single intravitreal injection of autologous bone marrow CD34+ stem cells. The number of cells to be injected per eye will range from 800,000 to 10 million, depending on the yield of the bone marrow aspiration and the isolation procedure. Sham Therapy: Sham bone marrow aspiration procedure that penetrates the skin, but does not penetrate the bone followed by sham intravitreal injection without penetration of the eye | 0 | 9 | 0 | 9 | 9 | 9 |
| Vitreous haemorrhage | Eye disorders | MedDRA (26.0) | Systematic Assessment |
|
| Iris Neovascularization | Eye disorders | MedDRA (26.0) | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA (26.0) | Systematic Assessment |
|
| Altered visual depth perception | Eye disorders | MedDRA (26.0) | Systematic Assessment |
|
| Cataract | Eye disorders | MedDRA (26.0) | Systematic Assessment |
|
| Cataract cortical | Eye disorders | MedDRA (26.0) | Systematic Assessment |
|
| Chalazion | Eye disorders | MedDRA (26.0) | Systematic Assessment |
|
| Cystoid macular oedema | Eye disorders | MedDRA (26.0) | Systematic Assessment |
|
| Dermatochalasis | Eye disorders | MedDRA (26.0) | Systematic Assessment |
|
| Dry eye | Eye disorders | MedDRA (26.0) | Systematic Assessment |
|
| Eye irritation | Eye disorders | MedDRA (26.0) | Systematic Assessment |
|
| Eye pain | Eye disorders | MedDRA (26.0) | Systematic Assessment |
|
| Eye pruritus | Eye disorders | MedDRA (26.0) | Systematic Assessment |
|
| Eye swelling | Eye disorders | MedDRA (26.0) | Systematic Assessment |
|
| Foreign body sensation in eyes | Eye disorders | MedDRA (26.0) | Systematic Assessment |
|
| Lacrimation increased | Eye disorders | MedDRA (26.0) | Systematic Assessment |
|
| Meibomian gland dysfunction | Eye disorders | MedDRA (26.0) | Systematic Assessment |
|
| Ocular hyperaemia | Eye disorders | MedDRA (26.0) | Systematic Assessment |
|
| Periorbital irritation | Eye disorders | MedDRA (26.0) | Systematic Assessment |
|
| Photopsia | Eye disorders | MedDRA (26.0) | Systematic Assessment |
|
| Presbyopia | Eye disorders | MedDRA (26.0) | Systematic Assessment |
|
| Retinal neovascularisation | Eye disorders | MedDRA (26.0) | Systematic Assessment |
|
| Swelling of eyelid | Eye disorders | MedDRA (26.0) | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA (26.0) | Systematic Assessment |
|
| Visual acuity reduced | Eye disorders | MedDRA (26.0) | Systematic Assessment |
|
| Visual impairment | Eye disorders | MedDRA (26.0) | Systematic Assessment |
|
| Vitreous degeneration | Eye disorders | MedDRA (26.0) | Systematic Assessment |
|
| Vitreous detachment | Eye disorders | MedDRA (26.0) | Systematic Assessment |
|
| Vitreous floaters | Eye disorders | MedDRA (26.0) | Systematic Assessment |
|
| Vitreous haemorrhage | Eye disorders | MedDRA (26.0) | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (26.0) | Systematic Assessment |
|
| Periodontal disease | Gastrointestinal disorders | MedDRA (26.0) | Systematic Assessment |
|
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA (26.0) | Systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA (26.0) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (26.0) | Systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA (26.0) | Systematic Assessment |
|
| Acarodermatitis | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
|
| Pharyngitis streptococcal | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
|
| Suspected COVID-19 | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA (26.0) | Systematic Assessment |
|
| Epicondylitis | Injury, poisoning and procedural complications | MedDRA (26.0) | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA (26.0) | Systematic Assessment |
|
| Heat exhaustion | Injury, poisoning and procedural complications | MedDRA (26.0) | Systematic Assessment |
|
| Immunisation reaction | Injury, poisoning and procedural complications | MedDRA (26.0) | Systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA (26.0) | Systematic Assessment |
|
| Rib fracture | Injury, poisoning and procedural complications | MedDRA (26.0) | Systematic Assessment |
|
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA (26.0) | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA (26.0) | Systematic Assessment |
|
| Gout | Metabolism and nutrition disorders | MedDRA (26.0) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | Systematic Assessment |
|
| Foot deformity | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | Systematic Assessment |
|
| Soft tissue mass | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | Systematic Assessment |
|
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (26.0) | Systematic Assessment |
|
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (26.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (26.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (26.0) | Systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA (26.0) | Systematic Assessment |
|
| Neuralgia | Nervous system disorders | MedDRA (26.0) | Systematic Assessment |
|
| Sciatica | Nervous system disorders | MedDRA (26.0) | Systematic Assessment |
|
| Panic attack | Psychiatric disorders | MedDRA (26.0) | Systematic Assessment |
|
| Chronic kidney disease | Renal and urinary disorders | MedDRA (26.0) | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (26.0) | Systematic Assessment |
|
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA (26.0) | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (26.0) | Systematic Assessment |
|
| Tooth extraction | Surgical and medical procedures | MedDRA (26.0) | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (26.0) | Systematic Assessment |
|
Not provided
Not provided
| D002318 |
| Cardiovascular Diseases |
| Disrupted (<900 microns) |
|
| Disrupted (900-1800 microns) |
|
| Disrupted (>1800 microns) |
|
| Cannot grade |
|
| Foveal Avascular Zone Integrity at Month 6 |
|