Central Retinal Vein Occlusion
Conditions
Keywords
Central Retinal Vein Occlusion, Retinal Vein Occlusion, Retinal Diseases, Eye Diseases, CD34+ Stem Cell Therapy, Autologous Bone Marrow Stem Cells, Stem Cells
Brief summary
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.
Detailed description
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.
Interventions
BIOLOGICALAutologous 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.
BIOLOGICALSham 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
Sponsors
National Eye Institute (NEI)
University of California, Davis
The Emmes Company, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
The participant, examining ophthalmologist, visual acuity examiner, photographers and OCT, perimetry, and ERG technicians will remain masked to study treatment assignment for study duration.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Study Eye Inclusion/
Exclusion criteria
Inclusion criteria for the study eye: * Clinical diagnosis of central retinal vein occlusion (CRVO) confirmed by review of medical records and screening assessment. * Best Corrected Visual Acuity (BCVA) obtained during the screening period is in the range of 20/40+ to 20/400- (ETDRS letter score in the range of 18 to 73, inclusive). * Duration of vision loss from CRVO \>= 6 months to \<=42 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence and Severity of Ocular and Systemic Adverse Events | Months 0 to 6 | 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. |
| Feasibility of the Stem Cell Therapy | Day 0 and Day 182 | Number of CD34+ cells isolated from the bone marrow aspirate and number of cells injected into the eye |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Average Threshold | Months 0 to 6 | Mean change from baseline of average threshold (dB) at Month 6 as measured by microperimetry (increase is better) |
| Change in Percent Normal Amplitude for ERG+OP (Oscillatory Potential) A-wave Under Scotopic Conditions | Months 0 to 6 | 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) |
| Change in Percent Normal Amplitude for ERG+OP B-wave Under Scotopic Conditions | Months 0 to 6 | 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) |
| Change in Percent Normal Latency of ERG+OP A-wave Under Scotopic Conditions | Months 0 to 6 | 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) |
| Change in Percent Normal Latency of ERG+OP B-wave Under Scotopic Conditions | Months 0 to 6 | 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) |
| Change in Percent Normal Amplitude for A-wave Under Photopic Conditions | Months 0 to 6 | 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) |
| Change in Percent Normal Amplitude for B-wave Under Photopic Conditions | Months 0 to 6 | 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) |
| Change in Percent Normal Latency for A-wave Under Photopic Conditions | Months 0 to 6 | 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) |
| Change in Percent Normal Latency for B-wave Under Photopic Conditions | Months 0 to 6 | 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) |
| Change in Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity Letter Score | Months 0 to 6 | 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. |
| Change in Flicker Latency Trough | Months 0 to 6 | Mean change from baseline of latency trough at Month 6 as measured by Full-field ERG (decrease is better) |
| Change in Percent Normal Amplitude for A-wave Under Scotopic Conditions | Months 0 to 6 | 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) |
| Change in Percent Normal Latency of A-wave Under Scotopic Conditions | Months 0 to 6 | 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) |
| Change in Percent Normal Amplitude for B-wave Under Scotopic Conditions | Months 0 to 6 | 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) |
| Change in Percent Normal Latency for B-wave Under Scotopic Conditions | Months 0 to 6 | 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) |
| Foveal Avascular Zone Integrity | 6 months | 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 |
| Change in Area of Non-perfusion Within ETDRS Grid | Months 0 to 6 | Mean change from baseline of area of non-perfusion within ETDRS grid at Month 6 as measured by fluorescein angiogram (decrease is better) |
| Change in Area of Non-perfusion Within Networc Grid | Months 0 to 6 | Mean change from baseline of area of non-perfusion within Networc grid at Month 6 as measured by fluorescein angiogram (decrease is better) |
| Change in Percent Normal Flicker Amplitude | Months 0 to 6 | Mean change from baseline in percent normal flicker amplitude at Month 6 as measured by Full-field ERG (increase is better) |
| Change in % Reduced Sensitivity | Months 0 to 6 | Mean change from baseline of % reduced sensitivity at Month 6 as measured by microperimetry (decrease is better) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 7 |
| 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 | 9 |
| Total | 16 |
Baseline characteristics
| Characteristic | Immediate Cellular Therapy / Deferred Sham Therapy | Immediate Sham Therapy / Deferred Cellular Therapy | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 5 Participants | 4 Participants | 9 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants | 5 Participants | 7 Participants |
| Age, Continuous | 67.9 years STANDARD_DEVIATION 12.59 | 62.7 years STANDARD_DEVIATION 12.62 | 64.9 years STANDARD_DEVIATION 12.47 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 7 Participants | 8 Participants | 15 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 7 Participants | 7 Participants | 14 Participants |
| Sex: Female, Male Female | 3 Participants | 2 Participants | 5 Participants |
| Sex: Female, Male Male | 4 Participants | 7 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 7 | 0 / 9 | 0 / 7 | 0 / 9 |
| other Total, other adverse events | 7 / 7 | 9 / 9 | 7 / 7 | 9 / 9 |
| serious Total, serious adverse events | 0 / 7 | 1 / 9 | 1 / 7 | 0 / 9 |
Outcome results
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
Time frame: Day 0 and Day 182
Population: All participants with successful bone marrow aspiration
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Immediate Cellular Therapy / Deferred Sham Therapy | Feasibility of the Stem Cell Therapy | Number of CD34+ cells isolated from the bone marrow aspirate (pre-release) | 5.4 Number of cells in millions | Standard Deviation 2.2 |
| Immediate Cellular Therapy / Deferred Sham Therapy | Feasibility of the Stem Cell Therapy | Number of CD34+ cells injected into the eye (pre-release) | 3.8 Number of cells in millions | Standard Deviation 1.69 |
| Immediate Sham Therapy / Deferred Cellular Therapy | Feasibility of the Stem Cell Therapy | Number of CD34+ cells isolated from the bone marrow aspirate (pre-release) | 5.9 Number of cells in millions | Standard Deviation 4.65 |
| Immediate Sham Therapy / Deferred Cellular Therapy | Feasibility of the Stem Cell Therapy | Number of CD34+ cells injected into the eye (pre-release) | 4.6 Number of cells in millions | Standard Deviation 4.14 |
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.
Time frame: Months 0 to 6
Population: Number of participants randomized
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Immediate Cellular Therapy / Deferred Sham Therapy | Incidence and Severity of Ocular and Systemic Adverse Events | Dermatochalasis in study eye | 0 participants |
| Immediate Cellular Therapy / Deferred Sham Therapy | Incidence and Severity of Ocular and Systemic Adverse Events | Altered visual depth perception in study eye | 1 participants |
| Immediate Cellular Therapy / Deferred Sham Therapy | Incidence and Severity of Ocular and Systemic Adverse Events | Chalazion in study eye | 0 participants |
| Immediate Cellular Therapy / Deferred Sham Therapy | Incidence and Severity of Ocular and Systemic Adverse Events | Cystoid macular oedema in study eye | 0 participants |
| Immediate Cellular Therapy / Deferred Sham Therapy | Incidence and Severity of Ocular and Systemic Adverse Events | Dry eye in study eye | 2 participants |
| Immediate Cellular Therapy / Deferred Sham Therapy | Incidence and Severity of Ocular and Systemic Adverse Events | Eye irritation in study eye | 5 participants |
| Immediate Cellular Therapy / Deferred Sham Therapy | Incidence and Severity of Ocular and Systemic Adverse Events | Eye pain in study eye | 4 participants |
| Immediate Cellular Therapy / Deferred Sham Therapy | Incidence and Severity of Ocular and Systemic Adverse Events | Eye puritis in study eye | 1 participants |
| Immediate Cellular Therapy / Deferred Sham Therapy | Incidence and Severity of Ocular and Systemic Adverse Events | Foreign body sensation in study eye | 2 participants |
| Immediate Cellular Therapy / Deferred Sham Therapy | Incidence and Severity of Ocular and Systemic Adverse Events | Meibomian gland dysfuntion in study eye | 1 participants |
| Immediate Cellular Therapy / Deferred Sham Therapy | Incidence and Severity of Ocular and Systemic Adverse Events | Ocular hyperaemia in study eye | 3 participants |
| Immediate Cellular Therapy / Deferred Sham Therapy | Incidence and Severity of Ocular and Systemic Adverse Events | Periorbital irritation in study eye | 0 participants |
| Immediate Cellular Therapy / Deferred Sham Therapy | Incidence and Severity of Ocular and Systemic Adverse Events | Photopsia in study eye | 0 participants |
| Immediate Cellular Therapy / Deferred Sham Therapy | Incidence and Severity of Ocular and Systemic Adverse Events | Presbyopia in study eye | 1 participants |
| Immediate Cellular Therapy / Deferred Sham Therapy | Incidence and Severity of Ocular and Systemic Adverse Events | Swelling of eyelid in study eye | 1 participants |
| Immediate Cellular Therapy / Deferred Sham Therapy | Incidence and Severity of Ocular and Systemic Adverse Events | Vision blurred in study eye | 1 participants |
| Immediate Cellular Therapy / Deferred Sham Therapy | Incidence and Severity of Ocular and Systemic Adverse Events | Visual acuity reduced in study eye | 0 participants |
| Immediate Cellular Therapy / Deferred Sham Therapy | Incidence and Severity of Ocular and Systemic Adverse Events | Visual impairment in study eye | 2 participants |
| Immediate Cellular Therapy / Deferred Sham Therapy | Incidence and Severity of Ocular and Systemic Adverse Events | Appendicitis | 0 participants |
| Immediate Cellular Therapy / Deferred Sham Therapy | Incidence and Severity of Ocular and Systemic Adverse Events | Vitreous degeneration in study eye | 1 participants |
| Immediate Cellular Therapy / Deferred Sham Therapy | Incidence and Severity of Ocular and Systemic Adverse Events | Vitreous detachment in study eye | 1 participants |
| Immediate Cellular Therapy / Deferred Sham Therapy | Incidence and Severity of Ocular and Systemic Adverse Events | Vitreous floaters in study eye | 6 participants |
| Immediate Cellular Therapy / Deferred Sham Therapy | Incidence and Severity of Ocular and Systemic Adverse Events | Cystoid macular oedema in fellow eye | 0 participants |
| Immediate Cellular Therapy / Deferred Sham Therapy | Incidence and Severity of Ocular and Systemic Adverse Events | Visual impairment in fellow eye | 1 participants |
| Immediate Cellular Therapy / Deferred Sham Therapy | Incidence and Severity of Ocular and Systemic Adverse Events | Vitreous floaters in fellow eye | 1 participants |
| Immediate Cellular Therapy / Deferred Sham Therapy | Incidence and Severity of Ocular and Systemic Adverse Events | Abdominal pain upper | 0 participants |
| Immediate Cellular Therapy / Deferred Sham Therapy | Incidence and Severity of Ocular and Systemic Adverse Events | Acarodermatitis | 0 participants |
| Immediate Cellular Therapy / Deferred Sham Therapy | Incidence and Severity of Ocular and Systemic Adverse Events | Anaemia | 0 participants |
| Immediate Cellular Therapy / Deferred Sham Therapy | Incidence and Severity of Ocular and Systemic Adverse Events | Arthralgia | 1 participants |
| Immediate Cellular Therapy / Deferred Sham Therapy | Incidence and Severity of Ocular and Systemic Adverse Events | Arthropod bite | 1 participants |
| Immediate Cellular Therapy / Deferred Sham Therapy | Incidence and Severity of Ocular and Systemic Adverse Events | Back pain | 1 participants |
| Immediate Cellular Therapy / Deferred Sham Therapy | Incidence and Severity of Ocular and Systemic Adverse Events | Basal cell carcinoma | 1 participants |
| Immediate Cellular Therapy / Deferred Sham Therapy | Incidence and Severity of Ocular and Systemic Adverse Events | Cholelithiasis | 1 participants |
| Immediate Cellular Therapy / Deferred Sham Therapy | Incidence and Severity of Ocular and Systemic Adverse Events | Chronic kidney disease | 1 participants |
| Immediate Cellular Therapy / Deferred Sham Therapy | Incidence and Severity of Ocular and Systemic Adverse Events | Dizziness | 1 participants |
| Immediate Cellular Therapy / Deferred Sham Therapy | Incidence and Severity of Ocular and Systemic Adverse Events | Epicondylitis | 0 participants |
| Immediate Cellular Therapy / Deferred Sham Therapy | Incidence and Severity of Ocular and Systemic Adverse Events | Fall | 0 participants |
| Immediate Cellular Therapy / Deferred Sham Therapy | Incidence and Severity of Ocular and Systemic Adverse Events | Foot deformity | 0 participants |
| Immediate Cellular Therapy / Deferred Sham Therapy | Incidence and Severity of Ocular and Systemic Adverse Events | Heat exhaustion | 0 participants |
| Immediate Cellular Therapy / Deferred Sham Therapy | Incidence and Severity of Ocular and Systemic Adverse Events | Hypertension | 2 participants |
| Immediate Cellular Therapy / Deferred Sham Therapy | Incidence and Severity of Ocular and Systemic Adverse Events | Immunisation reaction | 1 participants |
| Immediate Cellular Therapy / Deferred Sham Therapy | Incidence and Severity of Ocular and Systemic Adverse Events | Migraine | 0 participants |
| Immediate Cellular Therapy / Deferred Sham Therapy | Incidence and Severity of Ocular and Systemic Adverse Events | Neuralgia | 1 participants |
| Immediate Cellular Therapy / Deferred Sham Therapy | Incidence and Severity of Ocular and Systemic Adverse Events | Osteoarthritis | 1 participants |
| Immediate Cellular Therapy / Deferred Sham Therapy | Incidence and Severity of Ocular and Systemic Adverse Events | Pain in extremity | 1 participants |
| Immediate Cellular Therapy / Deferred Sham Therapy | Incidence and Severity of Ocular and Systemic Adverse Events | Palpitations | 1 participants |
| Immediate Cellular Therapy / Deferred Sham Therapy | Incidence and Severity of Ocular and Systemic Adverse Events | Procedural pain | 0 participants |
| Immediate Cellular Therapy / Deferred Sham Therapy | Incidence and Severity of Ocular and Systemic Adverse Events | Rash | 0 participants |
| Immediate Cellular Therapy / Deferred Sham Therapy | Incidence and Severity of Ocular and Systemic Adverse Events | Rectal haemorrhage | 0 participants |
| Immediate Cellular Therapy / Deferred Sham Therapy | Incidence and Severity of Ocular and Systemic Adverse Events | Rib fracture | 0 participants |
| Immediate Cellular Therapy / Deferred Sham Therapy | Incidence and Severity of Ocular and Systemic Adverse Events | Sciatica | 0 participants |
| Immediate Cellular Therapy / Deferred Sham Therapy | Incidence and Severity of Ocular and Systemic Adverse Events | Soft tissue mass | 1 participants |
| Immediate Cellular Therapy / Deferred Sham Therapy | Incidence and Severity of Ocular and Systemic Adverse Events | Squamous cell carcinoma of skin | 1 participants |
| Immediate Cellular Therapy / Deferred Sham Therapy | Incidence and Severity of Ocular and Systemic Adverse Events | Upper respiratory tract infection | 1 participants |
| Immediate Cellular Therapy / Deferred Sham Therapy | Incidence and Severity of Ocular and Systemic Adverse Events | White blood cell count decreased | 1 participants |
| Immediate Sham Therapy / Deferred Cellular Therapy | Incidence and Severity of Ocular and Systemic Adverse Events | Appendicitis | 1 participants |
| Immediate Sham Therapy / Deferred Cellular Therapy | Incidence and Severity of Ocular and Systemic Adverse Events | Anaemia | 1 participants |
| Immediate Sham Therapy / Deferred Cellular Therapy | Incidence and Severity of Ocular and Systemic Adverse Events | Migraine | 1 participants |
| Immediate Sham Therapy / Deferred Cellular Therapy | Incidence and Severity of Ocular and Systemic Adverse Events | Altered visual depth perception in study eye | 0 participants |
| Immediate Sham Therapy / Deferred Cellular Therapy | Incidence and Severity of Ocular and Systemic Adverse Events | Arthralgia | 0 participants |
| Immediate Sham Therapy / Deferred Cellular Therapy | Incidence and Severity of Ocular and Systemic Adverse Events | Chalazion in study eye | 1 participants |
| Immediate Sham Therapy / Deferred Cellular Therapy | Incidence and Severity of Ocular and Systemic Adverse Events | Rectal haemorrhage | 1 participants |
| Immediate Sham Therapy / Deferred Cellular Therapy | Incidence and Severity of Ocular and Systemic Adverse Events | Cystoid macular oedema in study eye | 1 participants |
| Immediate Sham Therapy / Deferred Cellular Therapy | Incidence and Severity of Ocular and Systemic Adverse Events | Dermatochalasis in study eye | 1 participants |
| Immediate Sham Therapy / Deferred Cellular Therapy | Incidence and Severity of Ocular and Systemic Adverse Events | Arthropod bite | 0 participants |
| Immediate Sham Therapy / Deferred Cellular Therapy | Incidence and Severity of Ocular and Systemic Adverse Events | Dry eye in study eye | 4 participants |
| Immediate Sham Therapy / Deferred Cellular Therapy | Incidence and Severity of Ocular and Systemic Adverse Events | Neuralgia | 0 participants |
| Immediate Sham Therapy / Deferred Cellular Therapy | Incidence and Severity of Ocular and Systemic Adverse Events | Eye irritation in study eye | 4 participants |
| Immediate Sham Therapy / Deferred Cellular Therapy | Incidence and Severity of Ocular and Systemic Adverse Events | Back pain | 1 participants |
| Immediate Sham Therapy / Deferred Cellular Therapy | Incidence and Severity of Ocular and Systemic Adverse Events | Eye pain in study eye | 2 participants |
| Immediate Sham Therapy / Deferred Cellular Therapy | Incidence and Severity of Ocular and Systemic Adverse Events | Upper respiratory tract infection | 1 participants |
| Immediate Sham Therapy / Deferred Cellular Therapy | Incidence and Severity of Ocular and Systemic Adverse Events | Eye puritis in study eye | 1 participants |
| Immediate Sham Therapy / Deferred Cellular Therapy | Incidence and Severity of Ocular and Systemic Adverse Events | Basal cell carcinoma | 0 participants |
| Immediate Sham Therapy / Deferred Cellular Therapy | Incidence and Severity of Ocular and Systemic Adverse Events | Foreign body sensation in study eye | 3 participants |
| Immediate Sham Therapy / Deferred Cellular Therapy | Incidence and Severity of Ocular and Systemic Adverse Events | Osteoarthritis | 0 participants |
| Immediate Sham Therapy / Deferred Cellular Therapy | Incidence and Severity of Ocular and Systemic Adverse Events | Meibomian gland dysfuntion in study eye | 1 participants |
| Immediate Sham Therapy / Deferred Cellular Therapy | Incidence and Severity of Ocular and Systemic Adverse Events | Cholelithiasis | 0 participants |
| Immediate Sham Therapy / Deferred Cellular Therapy | Incidence and Severity of Ocular and Systemic Adverse Events | Ocular hyperaemia in study eye | 3 participants |
| Immediate Sham Therapy / Deferred Cellular Therapy | Incidence and Severity of Ocular and Systemic Adverse Events | Rib fracture | 1 participants |
| Immediate Sham Therapy / Deferred Cellular Therapy | Incidence and Severity of Ocular and Systemic Adverse Events | Periorbital irritation in study eye | 1 participants |
| Immediate Sham Therapy / Deferred Cellular Therapy | Incidence and Severity of Ocular and Systemic Adverse Events | Chronic kidney disease | 0 participants |
| Immediate Sham Therapy / Deferred Cellular Therapy | Incidence and Severity of Ocular and Systemic Adverse Events | Photopsia in study eye | 1 participants |
| Immediate Sham Therapy / Deferred Cellular Therapy | Incidence and Severity of Ocular and Systemic Adverse Events | Pain in extremity | 0 participants |
| Immediate Sham Therapy / Deferred Cellular Therapy | Incidence and Severity of Ocular and Systemic Adverse Events | Presbyopia in study eye | 0 participants |
| Immediate Sham Therapy / Deferred Cellular Therapy | Incidence and Severity of Ocular and Systemic Adverse Events | Dizziness | 0 participants |
| Immediate Sham Therapy / Deferred Cellular Therapy | Incidence and Severity of Ocular and Systemic Adverse Events | Swelling of eyelid in study eye | 0 participants |
| Immediate Sham Therapy / Deferred Cellular Therapy | Incidence and Severity of Ocular and Systemic Adverse Events | Squamous cell carcinoma of skin | 0 participants |
| Immediate Sham Therapy / Deferred Cellular Therapy | Incidence and Severity of Ocular and Systemic Adverse Events | Vision blurred in study eye | 1 participants |
| Immediate Sham Therapy / Deferred Cellular Therapy | Incidence and Severity of Ocular and Systemic Adverse Events | Epicondylitis | 1 participants |
| Immediate Sham Therapy / Deferred Cellular Therapy | Incidence and Severity of Ocular and Systemic Adverse Events | Visual acuity reduced in study eye | 1 participants |
| Immediate Sham Therapy / Deferred Cellular Therapy | Incidence and Severity of Ocular and Systemic Adverse Events | Palpitations | 0 participants |
| Immediate Sham Therapy / Deferred Cellular Therapy | Incidence and Severity of Ocular and Systemic Adverse Events | Fall | 3 participants |
| Immediate Sham Therapy / Deferred Cellular Therapy | Incidence and Severity of Ocular and Systemic Adverse Events | Visual impairment in study eye | 0 participants |
| Immediate Sham Therapy / Deferred Cellular Therapy | Incidence and Severity of Ocular and Systemic Adverse Events | Sciatica | 1 participants |
| Immediate Sham Therapy / Deferred Cellular Therapy | Incidence and Severity of Ocular and Systemic Adverse Events | Vitreous degeneration in study eye | 0 participants |
| Immediate Sham Therapy / Deferred Cellular Therapy | Incidence and Severity of Ocular and Systemic Adverse Events | Foot deformity | 1 participants |
| Immediate Sham Therapy / Deferred Cellular Therapy | Incidence and Severity of Ocular and Systemic Adverse Events | Vitreous detachment in study eye | 0 participants |
| Immediate Sham Therapy / Deferred Cellular Therapy | Incidence and Severity of Ocular and Systemic Adverse Events | Procedural pain | 1 participants |
| Immediate Sham Therapy / Deferred Cellular Therapy | Incidence and Severity of Ocular and Systemic Adverse Events | Vitreous floaters in study eye | 0 participants |
| Immediate Sham Therapy / Deferred Cellular Therapy | Incidence and Severity of Ocular and Systemic Adverse Events | Heat exhaustion | 1 participants |
| Immediate Sham Therapy / Deferred Cellular Therapy | Incidence and Severity of Ocular and Systemic Adverse Events | Cystoid macular oedema in fellow eye | 1 participants |
| Immediate Sham Therapy / Deferred Cellular Therapy | Incidence and Severity of Ocular and Systemic Adverse Events | White blood cell count decreased | 0 participants |
| Immediate Sham Therapy / Deferred Cellular Therapy | Incidence and Severity of Ocular and Systemic Adverse Events | Visual impairment in fellow eye | 1 participants |
| Immediate Sham Therapy / Deferred Cellular Therapy | Incidence and Severity of Ocular and Systemic Adverse Events | Hypertension | 0 participants |
| Immediate Sham Therapy / Deferred Cellular Therapy | Incidence and Severity of Ocular and Systemic Adverse Events | Vitreous floaters in fellow eye | 1 participants |
| Immediate Sham Therapy / Deferred Cellular Therapy | Incidence and Severity of Ocular and Systemic Adverse Events | Rash | 1 participants |
| Immediate Sham Therapy / Deferred Cellular Therapy | Incidence and Severity of Ocular and Systemic Adverse Events | Abdominal pain upper | 1 participants |
| Immediate Sham Therapy / Deferred Cellular Therapy | Incidence and Severity of Ocular and Systemic Adverse Events | Immunisation reaction | 3 participants |
| Immediate Sham Therapy / Deferred Cellular Therapy | Incidence and Severity of Ocular and Systemic Adverse Events | Acarodermatitis | 1 participants |
| Immediate Sham Therapy / Deferred Cellular Therapy | Incidence and Severity of Ocular and Systemic Adverse Events | Soft tissue mass | 0 participants |
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)
Time frame: Months 0 to 6
Population: All participants with area of non-perfusion within ETDRS grid recorded at Month 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Cellular Therapy / Deferred Sham Therapy | Change in Area of Non-perfusion Within ETDRS Grid | 1.4 mm^2 | Standard Deviation 2.54 |
| Immediate Sham Therapy / Deferred Cellular Therapy | Change in Area of Non-perfusion Within ETDRS Grid | -3.3 mm^2 | Standard Deviation 6.32 |
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)
Time frame: Months 0 to 6
Population: All participants with area of non-perfusion within Networc grid recorded at Month 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Cellular Therapy / Deferred Sham Therapy | Change in Area of Non-perfusion Within Networc Grid | 0.2 mm^2 | Standard Deviation 152.7 |
| Immediate Sham Therapy / Deferred Cellular Therapy | Change in Area of Non-perfusion Within Networc Grid | 28.0 mm^2 | Standard Deviation 53.61 |
Secondary
Change in Average Threshold
Mean change from baseline of average threshold (dB) at Month 6 as measured by microperimetry (increase is better)
Time frame: Months 0 to 6
Population: All participants with average threshold recorded at Month 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Cellular Therapy / Deferred Sham Therapy | Change in Average Threshold | -1.2 dB | Standard Deviation 2.99 |
| Immediate Sham Therapy / Deferred Cellular Therapy | Change in Average Threshold | 0.0 dB | Standard Deviation 3.83 |
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.
Time frame: Months 0 to 6
Population: All participants with visual acuity letter score recorded at Month 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Cellular Therapy / Deferred Sham Therapy | Change in Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity Letter Score | 1.7 Letters read | Standard Deviation 3.82 |
| Immediate Sham Therapy / Deferred Cellular Therapy | Change in Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity Letter Score | 2.1 Letters read | Standard Deviation 10.98 |
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)
Time frame: Months 0 to 6
Population: All participants with latency trough recorded at Month 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Cellular Therapy / Deferred Sham Therapy | Change in Flicker Latency Trough | -4.2 percent latency trough | Standard Deviation 8.92 |
| Immediate Sham Therapy / Deferred Cellular Therapy | Change in Flicker Latency Trough | -0.3 percent latency trough | Standard Deviation 8.12 |
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)
Time frame: Months 0 to 6
Population: All participants with normal amplitude for a-wave under photopic conditions recorded at Month 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Cellular Therapy / Deferred Sham Therapy | Change in Percent Normal Amplitude for A-wave Under Photopic Conditions | 6.2 percent normal amplitude | Standard Deviation 35.84 |
| Immediate Sham Therapy / Deferred Cellular Therapy | Change in Percent Normal Amplitude for A-wave Under Photopic Conditions | 26.8 percent normal amplitude | Standard Deviation 79.01 |
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)
Time frame: Months 0 to 6
Population: All participants with normal amplitude for a-wave under scotopic conditions recorded at Month 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Cellular Therapy / Deferred Sham Therapy | Change in Percent Normal Amplitude for A-wave Under Scotopic Conditions | 8.2 percent normal amplitude | Standard Deviation 42.65 |
| Immediate Sham Therapy / Deferred Cellular Therapy | Change in Percent Normal Amplitude for A-wave Under Scotopic Conditions | 3.8 percent normal amplitude | Standard Deviation 48.29 |
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)
Time frame: Months 0 to 6
Population: All participants with normal amplitude for b-wave under photopic conditions recorded at Month 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Cellular Therapy / Deferred Sham Therapy | Change in Percent Normal Amplitude for B-wave Under Photopic Conditions | -2.5 percent normal amplitude | Standard Deviation 21.83 |
| Immediate Sham Therapy / Deferred Cellular Therapy | Change in Percent Normal Amplitude for B-wave Under Photopic Conditions | -6.0 percent normal amplitude | Standard Deviation 22.83 |
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)
Time frame: Months 0 to 6
Population: All participants with normal amplitude for b-wave under scotopic conditions recorded at Month 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Cellular Therapy / Deferred Sham Therapy | Change in Percent Normal Amplitude for B-wave Under Scotopic Conditions | -1.7 percent normal amplitude | Standard Deviation 35.75 |
| Immediate Sham Therapy / Deferred Cellular Therapy | Change in Percent Normal Amplitude for B-wave Under Scotopic Conditions | 19.2 percent normal amplitude | Standard Deviation 34.67 |
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)
Time frame: Months 0 to 6
Population: All participants with normal amplitude for ERG+OP b-wave under scotopic conditions recorded at Month 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Cellular Therapy / Deferred Sham Therapy | Change in Percent Normal Amplitude for ERG+OP B-wave Under Scotopic Conditions | -8.4 percent normal amplitude | Standard Deviation 48.94 |
| Immediate Sham Therapy / Deferred Cellular Therapy | Change in Percent Normal Amplitude for ERG+OP B-wave Under Scotopic Conditions | 11.6 percent normal amplitude | Standard Deviation 22.5 |
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)
Time frame: Months 0 to 6
Population: All participants with normal amplitude for ERG+OP a-wave under scotopic conditions recorded at Month 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Cellular Therapy / Deferred Sham Therapy | Change in Percent Normal Amplitude for ERG+OP (Oscillatory Potential) A-wave Under Scotopic Conditions | -7.7 percent normal amplitude | Standard Deviation 36.84 |
| Immediate Sham Therapy / Deferred Cellular Therapy | Change in Percent Normal Amplitude for ERG+OP (Oscillatory Potential) A-wave Under Scotopic Conditions | 18.6 percent normal amplitude | Standard Deviation 18.15 |
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)
Time frame: Months 0 to 6
Population: All participants with normal flicker amplitude recorded at Month 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Cellular Therapy / Deferred Sham Therapy | Change in Percent Normal Flicker Amplitude | -10.8 percent normal flicker amplitude | Standard Deviation 14.1 |
| Immediate Sham Therapy / Deferred Cellular Therapy | Change in Percent Normal Flicker Amplitude | 2.2 percent normal flicker amplitude | Standard Deviation 15.08 |
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)
Time frame: Months 0 to 6
Population: All participants with normal latency for a-wave under photopic conditions recorded at Month 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Cellular Therapy / Deferred Sham Therapy | Change in Percent Normal Latency for A-wave Under Photopic Conditions | -3.5 percent normal latency | Standard Deviation 20.19 |
| Immediate Sham Therapy / Deferred Cellular Therapy | Change in Percent Normal Latency for A-wave Under Photopic Conditions | -0.0 percent normal latency | Standard Deviation 13.08 |
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)
Time frame: Months 0 to 6
Population: All participants with normal latency for b-wave under photopic conditions recorded at Month 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Cellular Therapy / Deferred Sham Therapy | Change in Percent Normal Latency for B-wave Under Photopic Conditions | -0.1 percent normal latency | Standard Deviation 10.26 |
| Immediate Sham Therapy / Deferred Cellular Therapy | Change in Percent Normal Latency for B-wave Under Photopic Conditions | -4.7 percent normal latency | Standard Deviation 7.59 |
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)
Time frame: Months 0 to 6
Population: All participants with normal latency for b-wave under scotopic conditions recorded at Month 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Cellular Therapy / Deferred Sham Therapy | Change in Percent Normal Latency for B-wave Under Scotopic Conditions | -4.9 percent normal latency | Standard Deviation 12.32 |
| Immediate Sham Therapy / Deferred Cellular Therapy | Change in Percent Normal Latency for B-wave Under Scotopic Conditions | -5.7 percent normal latency | Standard Deviation 14.47 |
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)
Time frame: Months 0 to 6
Population: All participants with normal latency of a-wave under scotopic conditions recorded at Month 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Cellular Therapy / Deferred Sham Therapy | Change in Percent Normal Latency of A-wave Under Scotopic Conditions | 12.4 percent normal latency | Standard Deviation 56.19 |
| Immediate Sham Therapy / Deferred Cellular Therapy | Change in Percent Normal Latency of A-wave Under Scotopic Conditions | -14.7 percent normal latency | Standard Deviation 24.81 |
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)
Time frame: Months 0 to 6
Population: All participants with normal latency for a-wave under scotopic conditions recorded at Month 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Cellular Therapy / Deferred Sham Therapy | Change in Percent Normal Latency of ERG+OP A-wave Under Scotopic Conditions | 1.3 percent normal latency | Standard Deviation 21.59 |
| Immediate Sham Therapy / Deferred Cellular Therapy | Change in Percent Normal Latency of ERG+OP A-wave Under Scotopic Conditions | -9.0 percent normal latency | Standard Deviation 8.33 |
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)
Time frame: Months 0 to 6
Population: All participants with normal latency of ERG+OP b-wave under scotopic conditions recorded at Month 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Cellular Therapy / Deferred Sham Therapy | Change in Percent Normal Latency of ERG+OP B-wave Under Scotopic Conditions | 12.7 percent normal latency | Standard Deviation 42.38 |
| Immediate Sham Therapy / Deferred Cellular Therapy | Change in Percent Normal Latency of ERG+OP B-wave Under Scotopic Conditions | -1.2 percent normal latency | Standard Deviation 24.95 |
Secondary
Change in % Reduced Sensitivity
Mean change from baseline of % reduced sensitivity at Month 6 as measured by microperimetry (decrease is better)
Time frame: Months 0 to 6
Population: All participants with reduced sensitivity recorded at Month 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Cellular Therapy / Deferred Sham Therapy | Change in % Reduced Sensitivity | 0.8 percent reduced | Standard Deviation 14 |
| Immediate Sham Therapy / Deferred Cellular Therapy | Change in % Reduced Sensitivity | -11.4 percent reduced | Standard Deviation 16.81 |
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
Time frame: 6 months
Population: All participants with integrity of the foveal avascular zone recorded at Month 6
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Immediate Cellular Therapy / Deferred Sham Therapy | Foveal Avascular Zone Integrity | Foveal Avascular Zone Integrity at Baseline | Intact | 0 Participants |
| Immediate Cellular Therapy / Deferred Sham Therapy | Foveal Avascular Zone Integrity | Foveal Avascular Zone Integrity at Baseline | Questionable | 2 Participants |
| Immediate Cellular Therapy / Deferred Sham Therapy | Foveal Avascular Zone Integrity | Foveal Avascular Zone Integrity at Baseline | Disrupted (<900 microns) | 1 Participants |
| Immediate Cellular Therapy / Deferred Sham Therapy | Foveal Avascular Zone Integrity | Foveal Avascular Zone Integrity at Baseline | Disrupted (900-1800 microns) | 1 Participants |
| Immediate Cellular Therapy / Deferred Sham Therapy | Foveal Avascular Zone Integrity | Foveal Avascular Zone Integrity at Baseline | Disrupted (>1800 microns) | 3 Participants |
| Immediate Cellular Therapy / Deferred Sham Therapy | Foveal Avascular Zone Integrity | Foveal Avascular Zone Integrity at Baseline | Cannot grade | 0 Participants |
| Immediate Cellular Therapy / Deferred Sham Therapy | Foveal Avascular Zone Integrity | Foveal Avascular Zone Integrity at Month 6 | Intact | 0 Participants |
| Immediate Cellular Therapy / Deferred Sham Therapy | Foveal Avascular Zone Integrity | Foveal Avascular Zone Integrity at Month 6 | Questionable | 2 Participants |
| Immediate Cellular Therapy / Deferred Sham Therapy | Foveal Avascular Zone Integrity | Foveal Avascular Zone Integrity at Month 6 | Disrupted (<900 microns) | 2 Participants |
| Immediate Cellular Therapy / Deferred Sham Therapy | Foveal Avascular Zone Integrity | Foveal Avascular Zone Integrity at Month 6 | Disrupted (900-1800 microns) | 2 Participants |
| Immediate Cellular Therapy / Deferred Sham Therapy | Foveal Avascular Zone Integrity | Foveal Avascular Zone Integrity at Month 6 | Disrupted (>1800 microns) | 1 Participants |
| Immediate Cellular Therapy / Deferred Sham Therapy | Foveal Avascular Zone Integrity | Foveal Avascular Zone Integrity at Month 6 | Cannot grade | 0 Participants |
| Immediate Sham Therapy / Deferred Cellular Therapy | Foveal Avascular Zone Integrity | Foveal Avascular Zone Integrity at Month 6 | Disrupted (>1800 microns) | 0 Participants |
| Immediate Sham Therapy / Deferred Cellular Therapy | Foveal Avascular Zone Integrity | Foveal Avascular Zone Integrity at Baseline | Intact | 1 Participants |
| Immediate Sham Therapy / Deferred Cellular Therapy | Foveal Avascular Zone Integrity | Foveal Avascular Zone Integrity at Month 6 | Intact | 2 Participants |
| Immediate Sham Therapy / Deferred Cellular Therapy | Foveal Avascular Zone Integrity | Foveal Avascular Zone Integrity at Baseline | Questionable | 2 Participants |
| Immediate Sham Therapy / Deferred Cellular Therapy | Foveal Avascular Zone Integrity | Foveal Avascular Zone Integrity at Month 6 | Disrupted (900-1800 microns) | 4 Participants |
| Immediate Sham Therapy / Deferred Cellular Therapy | Foveal Avascular Zone Integrity | Foveal Avascular Zone Integrity at Baseline | Disrupted (<900 microns) | 2 Participants |
| Immediate Sham Therapy / Deferred Cellular Therapy | Foveal Avascular Zone Integrity | Foveal Avascular Zone Integrity at Month 6 | Questionable | 0 Participants |
| Immediate Sham Therapy / Deferred Cellular Therapy | Foveal Avascular Zone Integrity | Foveal Avascular Zone Integrity at Baseline | Disrupted (900-1800 microns) | 4 Participants |
| Immediate Sham Therapy / Deferred Cellular Therapy | Foveal Avascular Zone Integrity | Foveal Avascular Zone Integrity at Month 6 | Cannot grade | 1 Participants |
| Immediate Sham Therapy / Deferred Cellular Therapy | Foveal Avascular Zone Integrity | Foveal Avascular Zone Integrity at Baseline | Disrupted (>1800 microns) | 0 Participants |
| Immediate Sham Therapy / Deferred Cellular Therapy | Foveal Avascular Zone Integrity | Foveal Avascular Zone Integrity at Month 6 | Disrupted (<900 microns) | 2 Participants |
| Immediate Sham Therapy / Deferred Cellular Therapy | Foveal Avascular Zone Integrity | Foveal Avascular Zone Integrity at Baseline | Cannot grade | 0 Participants |