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| Name | Class |
|---|---|
| Regeneron Pharmaceuticals | INDUSTRY |
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The RECOVERY trial will assess the safety and tolerability of 2 mg intravitreal aflibercept injections (IAI) given monthly (Q4WK) or every 12 weeks (Q12WK) for the treatment of retinal capillary non-perfusion (RNP) associated with proliferative diabetic retinopathy (PDR).
The investigational product is intravitreal aflibercept injection, which will be supplied by Regeneron Pharmaceuticals, Inc. in sterile vials for intravitreal (IVT) injection. Vials must be used (defined as entered with needle) only once. All drug supplies are to be kept under recommended storage conditions.
The injection volume will be 50μL (0.05 mL) and will be administered to the subjects by IVT injection.
Study eyes will be assigned randomly (1:1 ratio) to one of the following 2 treatment arms:
Group 1- aflibercept 2 mg every 4 weeks (defined as every 28 days (+ 7 days) and at least 21 days between injections) through week 48. Subjects will have a mandatory Year 1 visit at week 48. Subjects have a mandatory visit at week 52 & will not receive treatment. During the second year of follow-up, subjects will be monitored and treated every 12 weeks (Week 60, 72, 84 and 96) with an end of study visit at week 100. If NV or PDR are worse per the pre-specified criteria at week 60, or at any study visit thereafter, the subject will be treated monthly through the end of the study.
Group 2 - aflibercept 2 mg every 12-weeks for 48 weeks. Subjects will be followed every 4 weeks through week 12, and can be treated if the pre-specified criteria are met. Starting at week 12 if NV or PDR are stable or improved (as assessed by investigator) the subject will be monitored and treated at a 12-week interval through week 48. If NV or PDR are worse per the pre-specified criteria at week 12, or at any study visit thereafter, the subject will be treated monthly through week 48. At week 52 -
Pre-specified criteria (subject must meet at least one criterion, which must be documented with imaging):
Rescue Treatment At any point throughout the study, for either treatment arm, if PDR progresses despite 3 monthly IAI, a fluorescein angiogram will be performed to evaluate PDR progression. PRP will only be permitted after confirmation of PDR progression with the primary
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Q4WKS | Experimental | Aflibercept 2 mg every 4 weeks (defined as every 28 days (+ 7 days) and at least 21 days between injections) through week 48. Following week 48, aflibercept 2 mg every 12 weeks through week 96. If NV or PDR are worse per pre-specified criteria at week 60, or at any study visit thereafter, the subject will be treated every 4 weeks through the end of the study. |
|
| Q12WKS | Experimental | Aflibercept 2 mg every 12-weeks. Subjects will be followed every 4 weeks through week 12, and can be treated if the pre-specified criteria are met. Starting at week 12 if NV or PDR are stable or improved (as assessed by investigator) the subject will be monitored and treated at a 12-week interval through week 48. If NV or PDR are worse per the pre-specified criteria at week 12, or at any study visit thereafter, the subject will be treated monthly through the end of the study. At week 52, aflibercept 2 mg every 4 weeks (defined as 28 days (+ 7 days) and at least 21 days between injections) for subjects with visible retinal non-perfusion. If retinal non-perfusion has completely resolved at week 72, aflibercept every 12 weeks through end of study. For subjects without retinal non-perfusion at week 52, aflibercept 2 mg every 12 weeks through the end of study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aflibercept | Drug | Intravitreal injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 | • Assess the safety and tolerability of IAI for the treatment of proliferative diabetic retinopathy by evaluating the incidence and severity of ocular and systemic adverse events through week 52 and week 100. | 52 and 100 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Early Treatment of Diabetic Retinopathy Severity Best Corrected Visual Acuity | Mean change in Early Treatment of Diabetic Retinopathy Study Best Corrected Visual Acuity (ETDRS-BCVA) from baseline to week 52 and week 100. | 52 weeks and 100 weeks |
| Change in Area of Retinal Capillary Non-perfusion Within the Macula |
Not provided
Inclusion Criteria:
Type 1 or type 2 diabetes mellitus
BCVA ETDRS > 20/400 in the study eye
Willing and able to comply with clinic visits and study-related procedures
Provide signed informed consent
Substantial non perfusion (defined as greater than 20 disc areas), as assessed by the investigator
Early PDR, as assessed by the investigator, with no vitreous hemorrhage*
Exclusion Criteria:
Any prior systemic anti-VEGF (anti vascular endothelial growth factor) or IVT anti-VEGF treatment in the study eye,
SD-OCT (Spectral Domain Optical Coherence Tomography) central subfield thickness measurement of > 320 µm, in the study eye
Evidence of infectious ocular infection, in the study eye, at time of screening
History of vitreoretinal surgery in the study eye
Any prior Panretinal laser photocoagulation (PRP) in the study eye
Current vitreous hemorrhage obscuring retinal imaging in the study eye
Cataract surgery in the study eye within 4 weeks of Day 0
Uncontrolled blood pressure (defined as > 180/110 mm Hg systolic/diastolic, while seated)
Significant renal disease defined as a history of chronic renal failure requiring dialysis or renal transplant
Tractional Retinal Detachment threatening the macula in the study eye
Corticosteroid treatment (intravitreal or peribulbar) in the study eye within 12 weeks of screening
Pregnant or breast-feeding women
Sexually active men* or women of childbearing potential who are unwilling to practice adequate contraception during the study. Adequate contraceptive measures include stable use of oral contraceptives or other prescription pharmaceutical contraceptives for 2 or more menstrual cycles prior to screening; intrauterine device (IUD); bilateral tubal ligation; vasectomy; condom plus contraceptive sponge, foam, or jelly, or diaphragm plus contraceptive sponge, foam, or jelly.
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| Name | Affiliation | Role |
|---|---|---|
| Charles C Wykoff, PhD, MD | Retina Consultants Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Retina Consultants of Houston/The Medical Center | Houston | Texas | 77030 | United States | ||
| Retina Consultants of Houston/Katy office |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15078674 | Background | Kempen JH, O'Colmain BJ, Leske MC, Haffner SM, Klein R, Moss SE, Taylor HR, Hamman RF; Eye Diseases Prevalence Research Group. The prevalence of diabetic retinopathy among adults in the United States. Arch Ophthalmol. 2004 Apr;122(4):552-63. doi: 10.1001/archopht.122.4.552. | |
| 4053957 | Background | Klein R, Klein BE, Moss SE. A population-based study of diabetic retinopathy in insulin-using patients diagnosed before 30 years of age. Diabetes Care. 1985 Sep-Oct;8 Suppl 1:71-6. doi: 10.2337/diacare.8.1.s71. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Q4WKS | Aflibercept 2 mg every 4 weeks (defined as every 28 days (+ 7 days) and at least 21 days between injections) through week 48. Following week 48, aflibercept 2 mg every 12 weeks through week 96. If NV or PDR are worse per pre-specified criteria at week 60, or at any study visit thereafter, the subject will be treated every 4 weeks through the end of the study. Aflibercept: Intravitreal injection |
| FG001 | Q12WKS | Aflibercept 2 mg every 12-weeks. Subjects will be followed every 4 weeks through week 12, and can be treated if the pre-specified criteria are met. Starting at week 12 if NV or PDR are stable or improved (as assessed by investigator) the subject will be monitored and treated at a 12-week interval through week 48. If NV or PDR are worse per the pre-specified criteria at week 12, or at any study visit thereafter, the subject will be treated monthly through the end of the study. At week 52, aflibercept 2 mg every 4 weeks (defined as 28 days (+ 7 days) and at least 21 days between injections) for subjects with visible retinal non-perfusion. If retinal non-perfusion has completely resolved at week 72, aflibercept every 12 weeks through end of study. For subjects without retinal non-perfusion at week 52, aflibercept 2 mg every 12 weeks through the end of study. Aflibercept: Intravitreal injection |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Year 1 |
|
| |||||||||||||||||||||
| Year 2 |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Q4WKS | Aflibercept 2 mg every 4 weeks (defined as every 28 days (+ 7 days) and at least 21 days between injections) through week 48. Following week 48, aflibercept 2 mg every 12 weeks through week 96. If NV or PDR are worse per pre-specified criteria at week 60, or at any study visit thereafter, the subject will be treated every 4 weeks through the end of the study. Aflibercept: Intravitreal injection |
| 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 Units |
| 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 | Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 | • Assess the safety and tolerability of IAI for the treatment of proliferative diabetic retinopathy by evaluating the incidence and severity of ocular and systemic adverse events through week 52 and week 100. | 3 participants that were enrolled dropped out before their Week 4 visit and were replaced in the study. Thus, only 40 subjects of the original 43 were followed and analyzed in the study. | Posted | Count of Participants | Participants | 52 and 100 weeks |
|
52 weeks and 100 weeks
3 participants that were enrolled dropped out before their Week 4 visit and were replaced in the study. Thus, only 40 subjects of the original 43 were followed and analyzed in the study.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Q4WKS | Aflibercept 2 mg every 4 weeks (defined as every 28 days (+ 7 days) and at least 21 days between injections) through week 48. Following week 48, aflibercept 2 mg every 12 weeks through week 96. If NV or PDR are worse per pre-specified criteria at week 60, or at any study visit thereafter, the subject will be treated every 4 weeks through the end of the study. Aflibercept: Intravitreal injection |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Worsening of Coronary Artery Disease | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Worsening Cataract | Eye disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Charles C. Wykoff | Retina Consultants of Houston | 713-524-3434 | ccwmd@houstonretina.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 19, 2017 | Feb 3, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 3, 2020 | Mar 24, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C533178 | aflibercept |
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Change in area of retinal capillary non-perfusion within the macula compared to baseline, as assessed by ultrawide-field fluorescein angiogram from baseline to week 52 and week 100. |
| 52 weeks and 100 weeks |
| Change in Area of Retinal Capillary Non-perfusion Outside of the Macula | Change in area of retinal capillary non-perfusion outside of the macula from baseline to week 52 and week 100. | 52 weeks and 100 weeks |
| Percentage of Subjects With Neovascularization Regression | Percentage of subjects with neovascularization regression (reduced area of neovascularization) as measured by the central image reading center from baseline to week 52 and week 100. | 52 Weeks and 100 Weeks |
| Percentage of Subjects With Increased Neovascularization | Percentage of subjects with increased neovascularization from baseline to week 52 and week 100. | 52 Weeks and 100 Weeks |
| Percentage of Subjects Who Develop Vitreous Hemorrhage | Percentage of subjects who develop vitreous hemorrhage from baseline to week 52 and week 100. | 52 Weeks and 100 Weeks |
| Percentage of Subjects Treated With Pan-retinal Photocoagulation or Vitrectomy | Percentage of subjects treated with PRP or vitrectomy for progression of PDR from baseline to week 52 and week 100. | 52 Weeks and 100 Weeks |
| Percentage of Subjects Who Develop Center-involving Diabetic Macular Edema | Percentage of subjects, at week 52 and week 100, who develop center-involving diabetic macular edema who did not have center-involving diabetic macular edema at baseline | 52 Weeks and 100 Weeks |
| Changes in Visual Function Outcomes (Self Reported Visual Function) | Changes in self reported visual function utilizing the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) from baseline to week 52 and week 100. The NEI VFQ is a validated measure of patient-reported visual function measured on a scale from 0 (worst function) to 100 (best function). | 52 weeks and 100 weeks |
| Mean Change in Central Subfield Thickness | Mean change in central subfield thickness (CST) from baseline to week 52 and week 100 | 52 weeks and 100 weeks |
| Change in Area of Total Retinal Capillary Non-perfusion, as Assessed by the Central Reading Center | Change in area of total retinal capillary non-perfusion, as assessed by the central reading center, at week 52 and week 100 compared to baseline. | 52 weeks and 100 weeks |
| Katy |
| Texas |
| 77494 |
| United States |
| Retina Consultants of Houston | Kingwood | Texas | 77339 | United States |
| Retina Consultants of Houston | The Woodlands | Texas | 77384 | United States |
| 944535 | Background | Preliminary report on effects of photocoagulation therapy. The Diabetic Retinopathy Study Research Group. Am J Ophthalmol. 1976 Apr;81(4):383-96. doi: 10.1016/0002-9394(76)90292-0. |
| 26565927 | Background | Writing Committee for the Diabetic Retinopathy Clinical Research Network; Gross JG, Glassman AR, Jampol LM, Inusah S, Aiello LP, Antoszyk AN, Baker CW, Berger BB, Bressler NM, Browning D, Elman MJ, Ferris FL 3rd, Friedman SM, Marcus DM, Melia M, Stockdale CR, Sun JK, Beck RW. Panretinal Photocoagulation vs Intravitreous Ranibizumab for Proliferative Diabetic Retinopathy: A Randomized Clinical Trial. JAMA. 2015 Nov 24;314(20):2137-2146. doi: 10.1001/jama.2015.15217. |
| 7196564 | Background | Photocoagulation treatment of proliferative diabetic retinopathy. Clinical application of Diabetic Retinopathy Study (DRS) findings, DRS Report Number 8. The Diabetic Retinopathy Study Research Group. Ophthalmology. 1981 Jul;88(7):583-600. |
| 2062512 | Background | Early photocoagulation for diabetic retinopathy. ETDRS report number 9. Early Treatment Diabetic Retinopathy Study Research Group. Ophthalmology. 1991 May;98(5 Suppl):766-85. |
| 8981711 | Background | Ferris F. Early photocoagulation in patients with either type I or type II diabetes. Trans Am Ophthalmol Soc. 1996;94:505-37. |
| 7526212 | Background | Aiello LP, Avery RL, Arrigg PG, Keyt BA, Jampel HD, Shah ST, Pasquale LR, Thieme H, Iwamoto MA, Park JE, et al. Vascular endothelial growth factor in ocular fluid of patients with diabetic retinopathy and other retinal disorders. N Engl J Med. 1994 Dec 1;331(22):1480-7. doi: 10.1056/NEJM199412013312203. |
| 22965590 | Background | Ip MS, Domalpally A, Hopkins JJ, Wong P, Ehrlich JS. Long-term effects of ranibizumab on diabetic retinopathy severity and progression. Arch Ophthalmol. 2012 Sep;130(9):1145-52. doi: 10.1001/archophthalmol.2012.1043. |
| 25439595 | Background | Ip MS, Domalpally A, Sun JK, Ehrlich JS. Long-term effects of therapy with ranibizumab on diabetic retinopathy severity and baseline risk factors for worsening retinopathy. Ophthalmology. 2015 Feb;122(2):367-74. doi: 10.1016/j.ophtha.2014.08.048. Epub 2014 Nov 18. |
| 26198808 | Background | Brown DM, Schmidt-Erfurth U, Do DV, Holz FG, Boyer DS, Midena E, Heier JS, Terasaki H, Kaiser PK, Marcus DM, Nguyen QD, Jaffe GJ, Slakter JS, Simader C, Soo Y, Schmelter T, Yancopoulos GD, Stahl N, Vitti R, Berliner AJ, Zeitz O, Metzig C, Korobelnik JF. Intravitreal Aflibercept for Diabetic Macular Edema: 100-Week Results From the VISTA and VIVID Studies. Ophthalmology. 2015 Oct;122(10):2044-52. doi: 10.1016/j.ophtha.2015.06.017. Epub 2015 Jul 18. |
| 25060610 | Background | Campochiaro PA, Wykoff CC, Singer M, Johnson R, Marcus D, Yau L, Sternberg G. Monthly versus as-needed ranibizumab injections in patients with retinal vein occlusion: the SHORE study. Ophthalmology. 2014 Dec;121(12):2432-42. doi: 10.1016/j.ophtha.2014.06.011. Epub 2014 Jul 21. |
| Background | Heier J. The Effect of Intravitreal Aflibercept on Capillary Non-perfusion in Patients with Proliferative Retinopathy and/or Macular Edema Secondary to Proliferative Diabetic Retinopathy and Central Retinal Venous Occlusive Disease (ANDROID Study). Retina Society, Paris, France. 2015. |
| 32829304 | Derived | Babiuch A, Wykoff CC, Hach J, Srivastava S, Talcott KE, Yu HJ, Nittala M, Sadda S, Ip MS, Le T, Hu M, Reese J, Ehlers JP. Longitudinal panretinal microaneurysm dynamics on ultra-widefield fluorescein angiography in eyes treated with intravitreal aflibercept for proliferative diabetic retinopathy in the recovery study. Br J Ophthalmol. 2021 Aug;105(8):1111-1115. doi: 10.1136/bjophthalmol-2020-316952. Epub 2020 Aug 22. |
| 32584384 | Derived | Alagorie AR, Nittala MG, Velaga S, Zhou B, Rusakevich AM, Wykoff CC, Sadda SR. Association of Intravitreal Aflibercept With Optical Coherence Tomography Angiography Vessel Density in Patients With Proliferative Diabetic Retinopathy: A Secondary Analysis of a Randomized Clinical Trial. JAMA Ophthalmol. 2020 Aug 1;138(8):851-857. doi: 10.1001/jamaophthalmol.2020.2130. |
| 31917731 | Derived | Babiuch AS, Wykoff CC, Srivastava SK, Talcott K, Zhou B, Hach J, Hu M, Reese JL, Ehlers JP. RETINAL LEAKAGE INDEX DYNAMICS ON ULTRA-WIDEFIELD FLUORESCEIN ANGIOGRAPHY IN EYES TREATED WITH INTRAVITREAL AFLIBERCEPT FOR PROLIFERATIVE DIABETIC RETINOPATHY IN THE RECOVERY STUDY. Retina. 2020 Nov;40(11):2175-2183. doi: 10.1097/IAE.0000000000002727. |
| Death |
|
| NOT COMPLETED |
|
|
| BG001 | Q12WKS | Aflibercept 2 mg every 12-weeks. Subjects will be followed every 4 weeks through week 12, and can be treated if the pre-specified criteria are met. Starting at week 12 if NV or PDR are stable or improved (as assessed by investigator) the subject will be monitored and treated at a 12-week interval through week 48. If NV or PDR are worse per the pre-specified criteria at week 12, or at any study visit thereafter, the subject will be treated monthly through the end of the study. At week 52, aflibercept 2 mg every 4 weeks (defined as 28 days (+ 7 days) and at least 21 days between injections) for subjects with visible retinal non-perfusion. If retinal non-perfusion has completely resolved at week 72, aflibercept every 12 weeks through end of study. For subjects without retinal non-perfusion at week 52, aflibercept 2 mg every 12 weeks through the end of study. Aflibercept: Intravitreal injection |
| BG002 | Total | Total of all reporting groups |
| Eyes |
|
| Eyes |
| Eyes |
|
|
| Age, Continuous | 3 subjects enrolled were withdrawn early in the trial and replaced. | Mean | Inter-Quartile Range | Years | Participants |
|
|
| Sex: Female, Male | Count of Units | Eyes | Eyes |
|
|
| Race (NIH/OMB) | 3 subjects enrolled were withdrawn early in the trial and replaced. | Count of Participants | Participants | Participants |
|
|
| Region of Enrollment | 3 subjects enrolled were withdrawn early in the trial and replaced. | Number | participants | Participants |
|
|
| OG001 | Q12WKS | Aflibercept 2 mg every 12-weeks. Subjects will be followed every 4 weeks through week 12, and can be treated if the pre-specified criteria are met. Starting at week 12 if NV or PDR are stable or improved (as assessed by investigator) the subject will be monitored and treated at a 12-week interval through week 48. If NV or PDR are worse per the pre-specified criteria at week 12, or at any study visit thereafter, the subject will be treated monthly through the end of the study. At week 52, aflibercept 2 mg every 4 weeks (defined as 28 days (+ 7 days) and at least 21 days between injections) for subjects with visible retinal non-perfusion. If retinal non-perfusion has completely resolved at week 72, aflibercept every 12 weeks through end of study. For subjects without retinal non-perfusion at week 52, aflibercept 2 mg every 12 weeks through the end of study. Aflibercept: Intravitreal injection |
|
|
| Secondary | Change in Early Treatment of Diabetic Retinopathy Severity Best Corrected Visual Acuity | Mean change in Early Treatment of Diabetic Retinopathy Study Best Corrected Visual Acuity (ETDRS-BCVA) from baseline to week 52 and week 100. | 3 participants that were enrolled dropped out before their Week 4 visit and were replaced in the study. Thus, only 40 subjects of the original 43 were followed and analyzed in the study. Number analyzed at Week 52 and Week 100 differs from overall number analyzed due to lost to follow up or deceased participants. | Posted | Mean | 95% Confidence Interval | ETDRS letters | 52 weeks and 100 weeks |
|
|
|
| Secondary | Change in Area of Retinal Capillary Non-perfusion Within the Macula | Change in area of retinal capillary non-perfusion within the macula compared to baseline, as assessed by ultrawide-field fluorescein angiogram from baseline to week 52 and week 100. | 3 participants that were enrolled dropped out before their Week 4 visit and were replaced in the study. Thus, only 40 subjects of the original 43 were followed and analyzed in the study. Number analyzed at Week 52 and Week 100 differs from overall number analyzed due to inability to analyze images, lost to follow up, or deceased participants. | Posted | Mean | Standard Deviation | mm^2 | 52 weeks and 100 weeks |
|
|
|
| Secondary | Change in Area of Retinal Capillary Non-perfusion Outside of the Macula | Change in area of retinal capillary non-perfusion outside of the macula from baseline to week 52 and week 100. | 3 participants that were enrolled dropped out before their Week 4 visit and were replaced in the study. Thus, only 40 subjects of the original 43 were followed and analyzed in the study. Number analyzed at Week 52 and Week 100 differs from overall number analyzed due to inability to analyze images, lost to follow up, or deceased participants. | Posted | Mean | Standard Deviation | mm^2 | 52 weeks and 100 weeks |
|
|
|
| Secondary | Percentage of Subjects With Neovascularization Regression | Percentage of subjects with neovascularization regression (reduced area of neovascularization) as measured by the central image reading center from baseline to week 52 and week 100. | 3 participants that were enrolled dropped out before their Week 4 visit and were replaced in the study. Thus, only 40 subjects of the original 43 were followed and analyzed in the study. Number analyzed at Week 52 and Week 100 differs from overall number analyzed due to inability to analyze images, lost to follow up, or deceased participants. | Posted | Count of Participants | Participants | 52 Weeks and 100 Weeks |
|
|
|
| Secondary | Percentage of Subjects With Increased Neovascularization | Percentage of subjects with increased neovascularization from baseline to week 52 and week 100. | 3 participants that were enrolled dropped out before their Week 4 visit and were replaced in the study. Thus, only 40 subjects of the original 43 were followed and analyzed in the study. Number analyzed at Week 52 and Week 100 differs from overall number analyzed due to inability to analyze images, lost to follow up, or deceased participants. | Posted | Count of Participants | Participants | 52 Weeks and 100 Weeks |
|
|
|
| Secondary | Percentage of Subjects Who Develop Vitreous Hemorrhage | Percentage of subjects who develop vitreous hemorrhage from baseline to week 52 and week 100. | 3 participants that were enrolled dropped out before their Week 4 visit and were replaced in the study. Thus, only 40 subjects of the original 43 were followed and analyzed in the study. | Posted | Count of Participants | Participants | 52 Weeks and 100 Weeks |
|
|
|
| Secondary | Percentage of Subjects Treated With Pan-retinal Photocoagulation or Vitrectomy | Percentage of subjects treated with PRP or vitrectomy for progression of PDR from baseline to week 52 and week 100. | 3 participants that were enrolled dropped out before their Week 4 visit and were replaced in the study. Thus, only 40 subjects of the original 43 were followed and analyzed in the study. | Posted | Count of Participants | Participants | 52 Weeks and 100 Weeks |
|
|
|
| Secondary | Percentage of Subjects Who Develop Center-involving Diabetic Macular Edema | Percentage of subjects, at week 52 and week 100, who develop center-involving diabetic macular edema who did not have center-involving diabetic macular edema at baseline | 3 participants that were enrolled dropped out before their Week 4 visit and were replaced in the study. Thus, only 40 subjects of the original 43 were followed and analyzed in the study. Number analyzed at Week 52 and Week 100 differs from overall number analyzed due to inability to analyze images, lost to follow up, or deceased participants. | Posted | Count of Participants | Participants | 52 Weeks and 100 Weeks |
|
|
|
| Secondary | Changes in Visual Function Outcomes (Self Reported Visual Function) | Changes in self reported visual function utilizing the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) from baseline to week 52 and week 100. The NEI VFQ is a validated measure of patient-reported visual function measured on a scale from 0 (worst function) to 100 (best function). | 3 participants that were enrolled dropped out before their Week 4 visit and were replaced in the study. Thus, only 40 subjects of the original 43 were followed and analyzed in the study. Number analyzed at Week 52 and Week 100 differs from overall number analyzed due to inability to analyze images, lost to follow up, or deceased participants. | Posted | Mean | Standard Deviation | units on a scale | 52 weeks and 100 weeks |
|
|
|
| Secondary | Mean Change in Central Subfield Thickness | Mean change in central subfield thickness (CST) from baseline to week 52 and week 100 | 3 participants that were enrolled dropped out before their Week 4 visit and were replaced in the study. Thus, only 40 subjects of the original 43 were followed and analyzed in the study. Number analyzed at Week 52 and Week 100 differs from overall number analyzed due to inability to analyze images, lost to follow up, or deceased participants. | Posted | Mean | Standard Deviation | micrometers | 52 weeks and 100 weeks |
|
|
|
| Secondary | Change in Area of Total Retinal Capillary Non-perfusion, as Assessed by the Central Reading Center | Change in area of total retinal capillary non-perfusion, as assessed by the central reading center, at week 52 and week 100 compared to baseline. | 3 participants that were enrolled dropped out before their Week 4 visit and were replaced in the study. Thus, only 40 subjects of the original 43 were followed and analyzed in the study. Number analyzed at Week 52 and Week 100 differs from overall number analyzed due to inability to analyze images, lost to follow up, or deceased participants. | Posted | Mean | Standard Deviation | mm^2 | 52 weeks and 100 weeks |
|
|
|
| 0 |
| 20 |
| 2 |
| 20 |
| 9 |
| 20 |
| EG001 | Q12WKS | Aflibercept 2 mg every 12-weeks. Subjects will be followed every 4 weeks through week 12, and can be treated if the pre-specified criteria are met. Starting at week 12 if NV or PDR are stable or improved (as assessed by investigator) the subject will be monitored and treated at a 12-week interval through week 48. If NV or PDR are worse per the pre-specified criteria at week 12, or at any study visit thereafter, the subject will be treated monthly through the end of the study. At week 52, aflibercept 2 mg every 4 weeks (defined as 28 days (+ 7 days) and at least 21 days between injections) for subjects with visible retinal non-perfusion. If retinal non-perfusion has completely resolved at week 72, aflibercept every 12 weeks through end of study. For subjects without retinal non-perfusion at week 52, aflibercept 2 mg every 12 weeks through the end of study. Aflibercept: Intravitreal injection | 1 | 20 | 2 | 20 | 8 | 20 |
| NSTEMI | Cardiac disorders | Systematic Assessment |
|
| Exacerbation of CHF | Cardiac disorders | Systematic Assessment |
|
| Hyperglycemia | Endocrine disorders | Systematic Assessment |
|
| Acute Osteomyelitis | Infections and infestations | Systematic Assessment |
|
| Bacteremia | Infections and infestations | Systematic Assessment |
|
| Subconjunctival Hemorrhage | Eye disorders | Systematic Assessment |
|
| Vitreous Hemorrhage | Eye disorders | Systematic Assessment |
|
| Floater | Ear and labyrinth disorders | Systematic Assessment |
|
| Photophobia | Eye disorders | Systematic Assessment |
|
| Eye Pain | Eye disorders | Systematic Assessment |
|
| Eye Irritation | Eye disorders | Systematic Assessment |
|
| Foreign body sensation | Eye disorders | Systematic Assessment |
|
| Ocular Burning | Eye disorders | Systematic Assessment |
|
| Dryness | Eye disorders | Systematic Assessment |
|
| Corneal Haze | Eye disorders | Systematic Assessment |
|
| Acute Follicular Conjunctivitis | Eye disorders | Systematic Assessment |
|
Not provided
Not provided
Not provided
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
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| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Week 100 |
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| Week 100 |
|
|
| Week 100 |
|
|
| Week 100 |
|
|
| Week 100 |
|
|
| Week 100 |
|
|
| Week 100 |
|
|
| Week 100 |
|
|
| Week 100 |
|
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