ProgSTAR: A Natural History of the Progression of Stargardt Disease: Retrospective and Prospective Studies
Study Details
Study Description
Brief Summary
Stargardt disease is currently an incurable and untreatable macular dystrophy that causes severe visual loss in children and young adults, thereby causing enormous morbidity with economic, psychological, emotional, and social implications. There are no FDA approved therapeutic treatments for this disease. Therefore, the objective of this study is to collect natural history data from a large population of children and adults in order to evaluate possible efficacy measures for planned clinical trials.
Participants will be recruited from each Investigator's own patient population as the study requires the availability of both multiyear retrospective data, as well as ongoing prospectively collected data. A concurrent ancillary study (SMART study) is also being conducted with a subset of the prospective study patients during their regular ProgSTAR study visits to expand the collection of retinal images to include microperimetry measurements gathered under scotopic (low light) conditions.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
Study Design
Outcome Measures
Primary Outcome Measures
- Yearly Progression Rate of Atrophic Lesions Using Fundus Autofluorescence (FAF) Images [2-12 years]
Yearly increase in area of decreased auto-fluorescence (DAF) which is defined as the sum of definite and questionable decreased auto-fluorescence
Secondary Outcome Measures
- Yearly Rate of Loss of Retinal Sensitivity as Measured by Scotopic Microperimetry (MP) [2 years]
The yearly rate of change in retinal sensitivity. Sensitivity tested with a Nidek MP-1 machine using a modified Humphrey 10-2 grid. The sensitivity was the average sensitivity from a 68-points test pattern (Prospective cohort only)
- Yearly Rate of Visual Acuity Loss [2-12 years]
Yearly change of visual acuity. Visual acuity measures of best-corrected or presenting VA extracted from medical record charts. Prospective cohort is best-corrected visual acuity using Early-Treatment Diabetic Retinopathy study methods
- Difference in the Rate of Retinal Sensitivity Change Per Year Between Photopic and Scotopic Micro-perimetry Testing [2 years]
Difference in the yearly rate of change in retinal sensitivity under photopic and scotopic conditions. Sensitivity tested with a Nidek MP-1. Scotopic sensitivity was obtained using a 40 points test pattern, and photopic sensitivity was obtained using a 68 points test pattern in a subset of Prospective cohort patients
- Yearly Rate of Loss of Overall Retinal Thickness [Participants followed at Baseline, 6 months, 12 months and 24 months]
Yearly decrease of overall retinal thickness using spectral domain optical coherence tomography (SD-OCT) scans from a 20° x 20° scan area centered on the fovea. Data are only available for the Prospective cohort.
- Yearly Rate of Loss of Outer Ring Retinal Thickness [Participants followed at Baseline, 6 months, 12 months and 24 months]
Yearly decrease of outer ring retinal thickness using SD-OCT scans from a 20° x 20° scan area centered on the fovea. Outer ring defined as ETDRS fields 1-4.
- Yearly Rate of Loss of the Inner Ring Retinal Thickness [Participants followed at Baseline, 6 months, 12 months and 24 months]
Yearly decrease of the inner ring retinal thickness using SD-OCT scans from a 20° x 20° scan area centered on the fovea. Inner ring defined as ETDRS fields 5-8. Data are only available for the Prospective cohort.
- Yearly Rate of Loss of the Central Ring Retinal Thickness [Participants followed at Baseline, 6 months, 12 months and 24 months]
Yearly decrease of the central ring retinal thickness using SD-OCT scans from a 20° x 20° scan area centered on the fovea. Central area defined as ETDRS fields 9. Data are only available for the Prospective cohort.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Provide a signed informed consent form and authorization allowing the disclosure and use of protected health information.
-
The designated primary study eye must have at least one well-demarcated area of atrophy as imaged by fundus autofluorescence with a minimum diameter of 300 microns and all lesions together must add to less than or equal to 12 mm2 (equivalent to no more than 5 disc areas in a least one eye) and a BCVA of 20 ETDRS letters (20/400 Snellen equivalent) or better.
-
Two (2) pathogenic mutations confirmed present, in the ABCA4 gene. If only one ABCA4 allele contains a pathogenic mutation, the patient shall have a typical Stargardt phenotype, namely at least one eye must have flecks at the level of the retinal pigment epithelium typical for STGD.
-
The primary study eye must have clear ocular media and adequate pupillary dilation to permit good quality fundus autofluorescence (FAF) and Spectral-Domain optical coherence tomography (sd-OCT) imaging in the opinion of the investigator.
-
Be able to cooperate in performing the examinations.
-
Be willing to undergo ocular examinations once every 6 months for up to 24 months.
-
Be at least six years old.
-
Both eyes can be included if inclusion criteria are fulfilled for both eyes.
Exclusion Criteria:
-
Ocular disease, such as choroidal neovascularization, glaucoma and diabetic retinopathy, in either eye that may confound assessment of the retina morphologically and functionally.
-
Intraocular surgery in the primary study eye within 90 days prior to baseline visit.
-
Current or previous participation in an interventional study to treat STGD such as gene therapy or stem cell therapy. Current participation in a drug trial or previous participation in a drug trial within six months before enrollment. The use of oral supplements of vitamins and minerals are permitted although the current use of Vitamin A supplementation shall be documented.
-
The site Principal Investigator may declare any patient at their site ineligible to participate in the study for a sound medical reason prior to the patient's enrollment into the study.
-
Any systemic disease with a limited survival prognosis (e.g. cancer, severe/unstable cardiovascular disease).
-
Any condition that would interfere with the patient attending their regular follow-up visits every 6 months for up to 24 months, e.g. personality disorder, use of major tranquilizers such as Haldol or Phenothiazine, chronic alcoholism, Alzheimer's Disease or drug abuse.
-
Evidence of significant uncontrolled concomitant diseases such as cardiovascular, neurological, pulmonary, renal, hepatic, endocrine or gastro-intestinal disorders.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Greater Baltimore Medical Center | Baltimore | Maryland | United States | 21204 |
| 2 | Wilmer Eye Institute, Johns Hopkins University | Baltimore | Maryland | United States | 21287 |
| 3 | Cole Eye Institute, Cleveland Clinic | Cleveland | Ohio | United States | 44195 |
| 4 | Scheie Eye Institute, University of Pennsylvania | Philadelphia | Pennsylvania | United States | 19104 |
| 5 | Retina Foundation of the Southwest | Dallas | Texas | United States | 75231 |
| 6 | Moran Eye Center, University of Utah | Salt Lake City | Utah | United States | 84132 |
| 7 | Institut de la Vision | Paris | France | 75012 | |
| 8 | Center for Ophthalmic Research, University of Teubingen | Tübingen | Germany | 72076 | |
| 9 | Moorfields Eye Hospital | London | United Kingdom | EC1V 2PD |
Sponsors and Collaborators
- Foundation Fighting Blindness
- United States Department of Defense
Investigators
- Study Chair: Hendrik Scholl, MD, Wilmer Eye Institute at the Johns Hopkins University
Study Documents (Full-Text)
More Information
Additional Information:
Publications
- Kong X, West SK, Strauss RW, Munoz B, Cideciyan AV, Michaelides M, Ho A, Ahmed M, Schönbach EM, Cheetham JK, Ervin AM, Scholl HPN; ProgStar study group. Progression of Visual Acuity and Fundus Autofluorescence in Recent-Onset Stargardt Disease: ProgStar Study Report #4. Ophthalmol Retina. 2017 Nov - Dec;1(6):514-523. doi: 10.1016/j.oret.2017.02.008. Epub 2017 Apr 28.
- Schönbach EM, Ibrahim MA, Strauss RW, Birch DG, Cideciyan AV, Hahn GA, Ho A, Kong X, Nasser F, Sunness JS, Zrenner E, Sadda SR, West SK, Scholl HPN; Progression of Stargardt Disease Study Group. Fixation Location and Stability Using the MP-1 Microperimeter in Stargardt Disease: ProgStar Report No. 3. Ophthalmol Retina. 2017 Jan - Feb;1(1):68-76. doi: 10.1016/j.oret.2016.08.009. Epub 2016 Oct 31.
- Schönbach EM, Wolfson Y, Strauss RW, Ibrahim MA, Kong X, Muñoz B, Birch DG, Cideciyan AV, Hahn GA, Nittala M, Sunness JS, Sadda SR, West SK, Scholl HPN; ProgStar Study Group. Macular Sensitivity Measured With Microperimetry in Stargardt Disease in the Progression of Atrophy Secondary to Stargardt Disease (ProgStar) Study: Report No. 7. JAMA Ophthalmol. 2017 Jul 1;135(7):696-703. doi: 10.1001/jamaophthalmol.2017.1162.
- Strauss RW, Muñoz B, Ho A, Jha A, Michaelides M, Mohand-Said S, Cideciyan AV, Birch D, Hariri AH, Nittala MG, Sadda S, Scholl HPN; ProgStar Study Group. Incidence of Atrophic Lesions in Stargardt Disease in the Progression of Atrophy Secondary to Stargardt Disease (ProgStar) Study: Report No. 5. JAMA Ophthalmol. 2017 Jul 1;135(7):687-695. doi: 10.1001/jamaophthalmol.2017.1121.
- FFBCRI-PROGSTAR-01/02
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Retrospective Cohort | Prospective Cohort |
|---|---|---|
| Arm/Group Description | Patients with at least two pathogenic mutations in the ABCA4 gene (or one mutation, but the clinical phenotype of flecks at the level of the RPE typical for STGD1). Participant's data are from clinical examinations and central reading center (RC) grading of retinal imaging (fundus auto-fluorescence, and spectral domain optical coherence tomography (OCT). | Patients with at least two pathogenic mutations in the ABCA4 gene (or one mutation, but the clinical phenotype of flecks at the level of the RPE typical for STGD1). Participant's data are from standardized clinical examinations and central reading center (RC) grading of retinal imaging (fundus auto-fluorescence, spectral domain optical coherence tomography (OCT) and micro-perimetry (optional). |
| Period Title: Total Study - Retrospective | ||
| STARTED | 251 | 0 |
| COMPLETED | 251 | 0 |
| NOT COMPLETED | 0 | 0 |
| Period Title: Total Study - Retrospective | ||
| STARTED | 0 | 259 |
| COMPLETED | 0 | 230 |
| NOT COMPLETED | 0 | 29 |
Baseline Characteristics
| Arm/Group Title | Retrospective Cohort | Prospective Cohort | Total |
|---|---|---|---|
| Arm/Group Description | Subjects with at least two pathogenic mutations in the ABCA4 gene (or one mutation, but the clinical phenotype of flecks at the level of the RPE typical for STGD1). Clinical data from multiple centers extracted from medical records. Participants were to have at least two visits with at least one of the study image modalities (fundus auto-fluorescence, micro-perimetry, or spectral domain optical coherence tomography (OCT)) | Multicenter prospective longitudinal cohort. Patients with at least two pathogenic mutations in the ABCA4 gene (or one mutation, but the clinical phenotype of flecks at the level of the RPE typical for STGD1). Participants were to have standardized visits at baseline and every 6 months for 24 months. Participant's data are from clinical examinations and central RC grading of retinal imaging (fundus auto-fluorescence, spectral domain optical coherence tomography (OCT)) and micro-perimetry. | Total of all reporting groups |
| Overall Participants | 251 | 259 | 510 |
| Age (Count of Participants) | |||
| <=18 years |
69
27.5%
|
51
19.7%
|
120
23.5%
|
| Between 18 and 65 years |
179
71.3%
|
201
77.6%
|
380
74.5%
|
| >=65 years |
3
1.2%
|
7
2.7%
|
10
2%
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
149
59.4%
|
141
54.4%
|
290
56.9%
|
| Male |
102
40.6%
|
118
45.6%
|
220
43.1%
|
| Race/Ethnicity, Customized (Count of Participants) | |||
| White/Middle Eastern |
174
69.3%
|
222
85.7%
|
396
77.6%
|
| Black or African American |
14
5.6%
|
20
7.7%
|
34
6.7%
|
| Asian/Indian |
10
4%
|
10
3.9%
|
20
3.9%
|
| Other |
5
2%
|
1
0.4%
|
6
1.2%
|
| More than one race |
2
0.8%
|
2
0.8%
|
4
0.8%
|
| Don't know/missing |
46
18.3%
|
4
1.5%
|
50
9.8%
|
| Region of Enrollment (participants) [Number] | |||
| United States |
90
35.9%
|
137
52.9%
|
227
44.5%
|
| United Kingdom |
79
31.5%
|
30
11.6%
|
109
21.4%
|
| France |
49
19.5%
|
48
18.5%
|
97
19%
|
| Germany |
33
13.1%
|
44
17%
|
77
15.1%
|
Outcome Measures
| Title | Yearly Progression Rate of Atrophic Lesions Using Fundus Autofluorescence (FAF) Images |
|---|---|
| Description | Yearly increase in area of decreased auto-fluorescence (DAF) which is defined as the sum of definite and questionable decreased auto-fluorescence |
| Time Frame | 2-12 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| Eyes of participants with at least 2 visits with gradable fundus auto-fluorescence images with atrophic lesions present |
| Arm/Group Title | Retrospective Cohort | Prospective Cohort |
|---|---|---|
| Arm/Group Description | Subjects with at least two pathogenic mutations in the ABCA4 gene (or one mutation, but the clinical phenotype of flecks at the level of the RPE typical for STGD1). Clinical data from multiple centers extracted from medical records. Participants were to have at least two visits with at least one of the study image modalities (fundus auto-fluorescence, micro-perimetry, or spectral domain optical coherence tomography (OCT)) | Multicenter prospective longitudinal cohort. Patients with at least two pathogenic mutations in the ABCA4 gene (or one mutation, but the clinical phenotype of flecks at the level of the RPE typical for STGD1). Participants were to have standardized visits at baseline and every 6 months for 24 months. Participant's data are from clinical examinations and central RC grading of retinal imaging (fundus auto-fluorescence, spectral domain optical coherence tomography (OCT)) and micro-perimetry. |
| Measure Participants | 215 | 259 |
| Measure eyes | 386 | 489 |
| Mean (95% Confidence Interval) [mm^2/year] |
0.35
|
0.64
|
| Title | Yearly Rate of Loss of Retinal Sensitivity as Measured by Scotopic Microperimetry (MP) |
|---|---|
| Description | The yearly rate of change in retinal sensitivity. Sensitivity tested with a Nidek MP-1 machine using a modified Humphrey 10-2 grid. The sensitivity was the average sensitivity from a 68-points test pattern (Prospective cohort only) |
| Time Frame | 2 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| Microperimetry data are available for only the Prospective cohort at centers with required equipment |
| Arm/Group Title | Retrospective Cohort | Prospective Cohort |
|---|---|---|
| Arm/Group Description | Subjects with at least two pathogenic mutations in the ABCA4 gene (or one mutation, but the clinical phenotype of flecks at the level of the RPE typical for STGD1). Clinical data from multiple centers extracted from medical records. Participants were to have at least two visits with at least one of the study image modalities (fundus auto-fluorescence, micro-perimetry, or spectral domain optical coherence tomography (OCT)) | Multicenter prospective longitudinal cohort. Patients with at least two pathogenic mutations in the ABCA4 gene (or one mutation, but the clinical phenotype of flecks at the level of the RPE typical for STGD1). Participants were to have standardized visits at baseline and every 6 months for 24 months. Participant's data are from clinical examinations and central RC grading of retinal imaging (fundus auto-fluorescence, spectral domain optical coherence tomography (OCT)) and micro-perimetry. |
| Measure Participants | 0 | 238 |
| Measure eyes | 0 | 449 |
| Mean (95% Confidence Interval) [dB/year] |
-0.76
|
| Title | Yearly Rate of Visual Acuity Loss |
|---|---|
| Description | Yearly change of visual acuity. Visual acuity measures of best-corrected or presenting VA extracted from medical record charts. Prospective cohort is best-corrected visual acuity using Early-Treatment Diabetic Retinopathy study methods |
| Time Frame | 2-12 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Retrospective Cohort | Prospective Cohort |
|---|---|---|
| Arm/Group Description | Subjects with at least two pathogenic mutations in the ABCA4 gene (or one mutation, but the clinical phenotype of flecks at the level of the RPE typical for STGD1). Clinical data from multiple centers extracted from medical records. Participants were to have at least two visits with at least one of the study image modalities (fundus auto-fluorescence, micro-perimetry, or spectral domain optical coherence tomography (OCT)) | Multicenter prospective longitudinal cohort. Patients with at least two pathogenic mutations in the ABCA4 gene (or one mutation, but the clinical phenotype of flecks at the level of the RPE typical for STGD1). Participants were to have standardized visits at baseline and every 6 months for 24 months. Participant's data are from clinical examinations and central RC grading of retinal imaging (fundus auto-fluorescence, spectral domain optical coherence tomography (OCT)) and micro-perimetry. |
| Measure Participants | 176 | 259 |
| Measure eyes | 332 | 489 |
| Mean (95% Confidence Interval) [logMAR/year] |
0.030
|
0.011
|
| Title | Difference in the Rate of Retinal Sensitivity Change Per Year Between Photopic and Scotopic Micro-perimetry Testing |
|---|---|
| Description | Difference in the yearly rate of change in retinal sensitivity under photopic and scotopic conditions. Sensitivity tested with a Nidek MP-1. Scotopic sensitivity was obtained using a 40 points test pattern, and photopic sensitivity was obtained using a 68 points test pattern in a subset of Prospective cohort patients |
| Time Frame | 2 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| Photopic microperimetry was obtained in a subset of patients, in a single designated study eye |
| Arm/Group Title | Retrospective Cohort | Prospective Cohort |
|---|---|---|
| Arm/Group Description | Subjects with at least two pathogenic mutations in the ABCA4 gene (or one mutation, but the clinical phenotype of flecks at the level of the RPE typical for STGD1). Clinical data from multiple centers extracted from medical records. Participants were to have at least two visits with at least one of the study image modalities (fundus auto-fluorescence, micro-perimetry, or spectral domain optical coherence tomography (OCT)) | Multicenter prospective longitudinal cohort. Patients with at least two pathogenic mutations in the ABCA4 gene (or one mutation, but the clinical phenotype of flecks at the level of the RPE typical for STGD1). Participants were to have standardized visits at baseline and every 6 months for 24 months. Participant's data are from clinical examinations and central RC grading of retinal imaging (fundus auto-fluorescence, spectral domain optical coherence tomography (OCT)) and micro-perimetry. |
| Measure Participants | 0 | 118 |
| Measure eyes | 0 | 118 |
| Mean (95% Confidence Interval) [dB/year] |
-0.78
|
| Title | Yearly Rate of Loss of Overall Retinal Thickness |
|---|---|
| Description | Yearly decrease of overall retinal thickness using spectral domain optical coherence tomography (SD-OCT) scans from a 20° x 20° scan area centered on the fovea. Data are only available for the Prospective cohort. |
| Time Frame | Participants followed at Baseline, 6 months, 12 months and 24 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| All visits of eligible eyes of the 258 participants with gradable overall thickness. Only OCT scans with adequate and fair quality are included |
| Arm/Group Title | Prospective Cohort |
|---|---|
| Arm/Group Description | Multicenter prospective longitudinal cohort. Patients with at least two pathogenic mutations in the ABCA4 gene (or one mutation, but the clinical phenotype of flecks at the level of the RPE typical for STGD1). OCT scans were graded by a central reading center. |
| Measure Participants | 258 |
| Measure eyes | 487 |
| Mean (95% Confidence Interval) [microns/year] |
-2.85
|
| Title | Yearly Rate of Loss of Outer Ring Retinal Thickness |
|---|---|
| Description | Yearly decrease of outer ring retinal thickness using SD-OCT scans from a 20° x 20° scan area centered on the fovea. Outer ring defined as ETDRS fields 1-4. |
| Time Frame | Participants followed at Baseline, 6 months, 12 months and 24 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| All visits of eligible eyes of the 258 participants with gradable thickness in the outer ring. Only OCT scans with adequate and fair quality are included |
| Arm/Group Title | Prospective Cohort |
|---|---|
| Arm/Group Description | Multicenter prospective longitudinal cohort. Patients with at least two pathogenic mutations in the ABCA4 gene (or one mutation, but the clinical phenotype of flecks at the level of the RPE typical for STGD1). OCT scans were graded by a central reading center. |
| Measure Participants | 258 |
| Measure eyes | 487 |
| Mean (95% Confidence Interval) [microns/year] |
-2.84
|
| Title | Yearly Rate of Loss of the Inner Ring Retinal Thickness |
|---|---|
| Description | Yearly decrease of the inner ring retinal thickness using SD-OCT scans from a 20° x 20° scan area centered on the fovea. Inner ring defined as ETDRS fields 5-8. Data are only available for the Prospective cohort. |
| Time Frame | Participants followed at Baseline, 6 months, 12 months and 24 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| All visits of eligible eyes of the 258 participants with gradable thickness in the inner ring. Only OCT scans with adequate and fair quality are included |
| Arm/Group Title | Prospective Cohort |
|---|---|
| Arm/Group Description | Multicenter prospective longitudinal cohort. Patients with at least two pathogenic mutations in the ABCA4 gene (or one mutation, but the clinical phenotype of flecks at the level of the RPE typical for STGD1). OCT scans were graded by a central reading center. |
| Measure Participants | 258 |
| Measure eyes | 487 |
| Mean (95% Confidence Interval) [microns/year] |
-3.20
|
| Title | Yearly Rate of Loss of the Central Ring Retinal Thickness |
|---|---|
| Description | Yearly decrease of the central ring retinal thickness using SD-OCT scans from a 20° x 20° scan area centered on the fovea. Central area defined as ETDRS fields 9. Data are only available for the Prospective cohort. |
| Time Frame | Participants followed at Baseline, 6 months, 12 months and 24 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| All visits of eligible eyes of the 258 participants with gradable thickness in the inner ring. Only OCT scans with adequate and fair quality are included |
| Arm/Group Title | Prospective Cohort |
|---|---|
| Arm/Group Description | Multicenter prospective longitudinal cohort. Patients with at least two pathogenic mutations in the ABCA4 gene (or one mutation, but the clinical phenotype of flecks at the level of the RPE typical for STGD1). OCT scans were graded by a central reading center. |
| Measure Participants | 258 |
| Measure eyes | 487 |
| Mean (95% Confidence Interval) [microns/year] |
-2.24
|
Adverse Events
| Time Frame | Adverse events were not collected in this natural history study | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | As there was no intervention in this study, adverse events were not collected | |||
| Arm/Group Title | Retrospective Cohort | Prospective Cohort | ||
| Arm/Group Description | Subjects with at least two pathogenic mutations in the ABCA4 gene (or one mutation, but the clinical phenotype of flecks at the level of the RPE typical for STGD1). Clinical data from multiple centers extracted from medical records. Participants should had at least two visits with at least one of the study image modalities (fundus auto-fluorescence, micro-perimetry, or spectral domain optical coherence tomography (OCT)). Adverse events were not collected | Multicenter prospective longitudinal cohort. Patients with at least two pathogenic mutations in the ABCA4 gene (or one mutation, but the clinical phenotype of flecks at the level of the RPE typical for STGD1). Participants had standardized visits at baseline and every 6 months for 24 months. Participant's data are from clinical examinations and central RC grading of retinal imaging (fundus auto-fluorescence, spectral domain optical coherence tomography (OCT)) and micro-perimetry. Adverse events were not collected | ||
All Cause Mortality |
||||
| Retrospective Cohort | Prospective Cohort | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/251 (0%) | 1/259 (0.4%) | ||
Serious Adverse Events |
||||
| Retrospective Cohort | Prospective Cohort | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/0 (NaN) | 0/0 (NaN) | ||
Other (Not Including Serious) Adverse Events |
||||
| Retrospective Cohort | Prospective Cohort | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/0 (NaN) | 0/0 (NaN) | ||
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Chief Scientific Officer |
|---|---|
| Organization | Foundation Fighting Blindness |
| Phone | 410-423-0600 |
| info@FightBlindness.org |
- FFBCRI-PROGSTAR-01/02