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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-001764-29 | EudraCT Number |
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The primary objective of the study is to assess the efficacy of aflibercept compared to laser in patients diagnosed with retinopathy of prematurity (ROP). The secondary objectives of the study are to assess the need for a second treatment modality, to assess the recurrence of ROP in the study and to assess the safety and tolerability of aflibercept.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aflibercept Group | Experimental | Patients will receive a single intravitreal (IVT) injection per eligible eye at baseline. |
|
| Laser Group | Experimental | Patients will undergo laser treatment in each eligible eye at baseline. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| aflibercept | Drug | Administered IVT |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Absence of Active Retinopathy of Prematurity (ROP) and Unfavorable Structural Outcomes From Baseline to Week 52 of Chronological Age | Active ROP was ROP requiring treatment and unfavorable structural outcome was defined as retinal detachment, macular dragging, macular fold, or retrolental opacity. For participants with both eyes enrolled in the study, both eyes must have met the endpoint. Participants with only one study eye enrolled were responders if the respective eye responded. | Baseline to week 52 of chronological age |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Requiring Intervention With a Second Treatment Modality From Baseline to Week 52 of Chronological Age | Second treatment modality includes any treatment in addition to that assigned to the participant at baseline. This includes per-protocol rescue treatment (laser for aflibercept group, aflibercept for laser group), anti-VEGF agents not part of study protocol (e.g., bevacizumab, ranibizumab, commercially-available aflibercept not provided as study medication), or any ocular surgery for the management of any retinal pathology secondary to ROP (e.g., victrectomy, scleral buckle for retinal detachments). |
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Key Inclusion Criteria:
Gestational age at birth ≤ 32 weeks or birth weight ≤1500 g
Patients with treatment-naïve retinopathy of prematurity (ROP) classified according to the International Classification for ROP in at least one eye as:
Key Exclusion Criteria:
NOTE: Other protocol defined inclusion/exclusion criteria apply.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Management | Regeneron Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Regeneron Study Site | Phoenix | Arizona | 85016 | United States | ||
| Regeneron Study Site |
All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
Individual anonymized participant data will be considered for sharing once the indication has been approved by a regulatory body, if there is legal authority to share the data and there is not a reasonable likelihood of participant re-identification.
Qualified researchers may request access to anonymized patient level data or aggregate study data when Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc) for the product and indication, has the legal authority to share the data, and has made the study results publicly available (eg, scientific publication, scientific conference, clinical trial registry).
Of the 127 participants randomized, 33 were randomized to laser and 94 were randomized to aflibercept. Six of the 33 participants randomized to laser were withdrawn before receiving any study intervention (5 due to Parent/Guardian and 1 due to Physician decision); One of the 94 participants randomized to aflibercept was withdrawn before receiving any study intervention due to Parent/Guardian. In total, 120 participants (27, laser group; 93, aflibercept group) received at least 1 study treatment.
137 participants were screened, 127 were randomized.
| ID | Title | Description |
|---|---|---|
| FG000 | Laser Photocoagulation | Participants received laser treatment to each eligible eye at baseline (Day 1), with supplementary laser treatments allowed. Multiple sessions within one week from baseline were counted as a single treatment. If both eyes were eligible, they were assigned to the same treatment group. |
| FG001 |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 29, 2019 | Jun 12, 2023 |
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Open-Label
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| laser photocoagulation | Procedure | Transpupillary conventional laser will be administered according to standard local procedures. |
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| Baseline to to week 52 of chronological age |
| Percentage of Participants With Recurrence of ROP Through Week 52 of Chronological Age | Recurrence of disease is defined as the reappearance of the disease requiring further treatment (including retreatment or rescue), where both "presence of ROP" and "presence of active ROP requiring treatment" are marked as "Yes", after initial regression. Here, the initial regression is defined as, at a particular visit, absence of ROP or ROP treatment not required for active ROP, i.e., presence of ROP is marked as "No" or the presence of active ROP requiring treatment is marked as "No." | Baseline to week 52 of chronological age |
| Percentage of Participants With Ocular Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | Baseline to Week 52 of chronological age |
| Percentage of Participants With Systematic (Non-ocular) TEAEs and TESAEs | Baseline to Week 52 of chronological age |
| La Jolla |
| California |
| 92093 |
| United States |
| Regeneron Study Site | Loma Linda | California | 92354 | United States |
| Regeneron Study Site | Orange | California | 92868 | United States |
| Regeneron Study Site | Palo Alto | California | 94303 | United States |
| Regeneron Study Site | San Diego | California | 92123 | United States |
| Regeneron Study Site | San Francisco | California | 94143 | United States |
| Regeneron Study Site | Gainesville | Florida | 32608 | United States |
| Regeneron Study Site | Augusta | Georgia | 78705 | United States |
| Regeneron Study Site | Chicago | Illinois | 60612 | United States |
| Regeneron Study Site | Boston | Massachusetts | 02111 | United States |
| Regeneron Study Site | Ann Arbor | Michigan | 48105 | United States |
| Regeneron Study Site | Royal Oak | Michigan | 48073 | United States |
| Regeneron Study Site | Brooklyn | New York | 11203 | United States |
| Regeneron Study Site | Brooklyn | New York | 11213 | United States |
| Regeneron Study Site | Buffalo | New York | 14209 | United States |
| Regeneron Study Site | New York | New York | 10017 | United States |
| Regeneron Study Site | New York | New York | 10029 | United States |
| Regeneron Study Site | The Bronx | New York | 10462 | United States |
| Regeneron Study Site | Valhalla | New York | 10595 | United States |
| Regeneron Study Site | Cleveland | Ohio | 44106 | United States |
| Regeneron Study Site | Oklahoma City | Oklahoma | 73104 | United States |
| Regeneron Study Site | Providence | Rhode Island | 02905 | United States |
| Regeneron Study Site | Austin | Texas | 78705 | United States |
| Regeneron Study Site | San Antonio | Texas | 78229 | United States |
| Regeneron Study Site | San Antonio | Texas | 78240 | United States |
| Regeneron Study Site | Morgantown | West Virginia | 26506 | United States |
| Regeneron Study Site | Sofia | 1407 | Bulgaria |
| Regeneron Study Site | Sofia | 1504 | Bulgaria |
| Regeneron Study Site | Varna | 9002 | Bulgaria |
| Regeneron Study Site | MedellÃn | Antioquia | 50034 | Colombia |
| Regeneron Study Site | Floridablanca | Santander Department | 681004 | Colombia |
| Regeneron Study Site | Ostrava-Poruba | 708 52 | Czechia |
| Regeneron Study Site | Debrecen | H-4032 | Hungary |
| Regeneron Study Site | Iași | 700038 | Romania |
| Regeneron Study Site | Saint Petersburg | Sankt-Peterburg | 194100 | Russia |
| Regeneron Study Site | Moscow | 119571 | Russia |
| Regeneron Study Site | Moscow | 119620 | Russia |
| Regeneron Study Site | Bratislava | 833 40 | Slovakia |
| Regeneron Study Site | Cheonan | 31151 | South Korea |
| Regeneron Study Site | Kaohsiung City | 81346 | Taiwan |
| Regeneron Study Site | Pathum Wan | Bangkok | 10330 | Thailand |
| Regeneron Study Site | Ratchathewi | Bangkok | 10400 | Thailand |
| Regeneron Study Site | Hat Yai | Changwat Songkhla | 90110 | Thailand |
| Regeneron Study Site | Chiang Mai | Chiang Mai | 50200 | Thailand |
| Regeneron Study Site | Khon Kaen | 40002 | Thailand |
| Regeneron Study Site | Adana | 4522 | Turkey (Türkiye) |
| Regeneron Study Site | Ankara | 06100 | Turkey (Türkiye) |
| Regeneron Study Site | Ankara | 06560 | Turkey (Türkiye) |
| Regeneron Study Site | Eskişehir | 26480 | Turkey (Türkiye) |
| Regeneron Study Site | Ho Chi Minh City | 70000 | Vietnam |
| Regeneron Study Site | Huế | 100000 | Vietnam |
| Aflibercept 0.4 mg |
Participants received one intravitreal injection of aflibercept 0.4 mg (0.01 mL) per eligible eye at baseline (Day 1), with up to 2 re-injections at the same single dose allowed for each eligible eye if required and interval since last aflibercept injection was 28 or more days. If both eyes were eligible, they were assigned to the same treatment group. |
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| COMPLETED |
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| NOT COMPLETED |
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Full analysis set (FAS): All randomized participants who received any study treatment. Eyes analyzed includes all treated eyes.
| ID | Title | Description |
|---|---|---|
| BG000 | Laser Photocoagulation | Participants received laser treatment to each eligible eye at baseline (Day 1), with supplementary laser treatments allowed. Multiple sessions within one week from baseline were counted as a single treatment. If both eyes were eligible, they were assigned to the same treatment group. |
| BG001 | Aflibercept 0.4 mg | Participants received one intravitreal injection of aflibercept 0.4 mg (0.01 mL) per eligible eye at baseline (Day 1), with up to 2 re-injections at the same single dose allowed for each eligible eye if required and interval since last aflibercept injection was 28 or more days. If both eyes were eligible, they were assigned to the same treatment group. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Eyes |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Chronological Age at Randomization (date of randomization - date of birth + 1) | Mean | Standard Deviation | Weeks | Participants |
| |||||||||||||
| Sex: Female, Male | Count of Participants | Participants | Participants |
| |||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants | Participants |
| |||||||||||||||
| Race/Ethnicity, Customized | Race | Number | Participants | Participants |
| ||||||||||||||
| Retinopathy of prematurity (ROP) Zone, by eye | ROP was classified by the investigator according to the International Classification for ROP in at least 1 eye with 1 of the following retinal findings: Zone I, or Zone II, or AP(aggressive posterior)-ROP (Zone I, Zone II). Zone I is the innermost zone of the retina centered around the optic disc, surrounded by the more peripheral Zone II. AP-ROP is a rapidly progressive form of ROP, with posterior location, commonly observed in Zone I, less common in posterior Zone II. AP-ROP, if untreated, usually progresses to retinal detachment. Eyes with AP-ROP are not always exclusive of disease stage. | Count of Units | Eyes | Eyes |
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| 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 | Percentage of Participants With Absence of Active Retinopathy of Prematurity (ROP) and Unfavorable Structural Outcomes From Baseline to Week 52 of Chronological Age | Active ROP was ROP requiring treatment and unfavorable structural outcome was defined as retinal detachment, macular dragging, macular fold, or retrolental opacity. For participants with both eyes enrolled in the study, both eyes must have met the endpoint. Participants with only one study eye enrolled were responders if the respective eye responded. | Full analysis set (FAS): All randomized participants who received any study treatment. Analysis on the FAS was performed according to the treatment assigned at baseline (as randomized). | Posted | Number | Percentage of participants | Baseline to week 52 of chronological age |
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| Secondary | Percentage of Participants Requiring Intervention With a Second Treatment Modality From Baseline to Week 52 of Chronological Age | Second treatment modality includes any treatment in addition to that assigned to the participant at baseline. This includes per-protocol rescue treatment (laser for aflibercept group, aflibercept for laser group), anti-VEGF agents not part of study protocol (e.g., bevacizumab, ranibizumab, commercially-available aflibercept not provided as study medication), or any ocular surgery for the management of any retinal pathology secondary to ROP (e.g., victrectomy, scleral buckle for retinal detachments). | Full analysis set (FAS): All randomized participants who received any study treatment. | Posted | Number | Percentage of participants | Baseline to to week 52 of chronological age |
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| Secondary | Percentage of Participants With Recurrence of ROP Through Week 52 of Chronological Age | Recurrence of disease is defined as the reappearance of the disease requiring further treatment (including retreatment or rescue), where both "presence of ROP" and "presence of active ROP requiring treatment" are marked as "Yes", after initial regression. Here, the initial regression is defined as, at a particular visit, absence of ROP or ROP treatment not required for active ROP, i.e., presence of ROP is marked as "No" or the presence of active ROP requiring treatment is marked as "No." | Full analysis set (FAS): All randomized participants who received any study treatment. | Posted | Number | Percentage of participants | Baseline to week 52 of chronological age |
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| Secondary | Percentage of Participants With Ocular Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | Safety analysis set (SAF): All randomized participants who received any study treatment (active or laser); it is based on the treatment actually received (as treated). | Posted | Number | Percentage of participants | Baseline to Week 52 of chronological age |
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| Secondary | Percentage of Participants With Systematic (Non-ocular) TEAEs and TESAEs | Safety analysis set (SAF): All randomized participants who received any study treatment (active or laser); it is based on the treatment actually received (as treated). | Posted | Number | Percentage of participants | Baseline to Week 52 of chronological age |
|
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From signing of informed consent form (ICF) to end of study (week 52 of chronological age visit), an average of 42 weeks
Thirty-three (33) participants were randomized to laser and 94 participants randomized to aflibercept; however, 6 laser participants and 1 aflibercept participant were not treated and therefore, excluded from the safety analysis set (SAF) and FAS. SAF and FAS populations are identical: 27 laser group; 93 aflibercept group.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Laser Photocoagulation | Participants received laser treatment to each eligible eye at baseline (Day 1), with supplementary laser treatments allowed. Multiple sessions within one week from baseline were counted as a single treatment. If both eyes were eligible, they were assigned to the same treatment group. | 0 | 27 | 12 | 27 | 12 | 27 |
| EG001 | Aflibercept 0.4 mg | Participants received one intravitreal injection of aflibercept 0.4 mg (0.01 mL) per eligible eye at baseline (Day 1), with up to 2 re-injections at the same single dose allowed for each eligible eye if required and interval since last aflibercept injection was 28 or more days. If both eyes were eligible, they were assigned to the same treatment group. | 1 | 93 | 32 | 93 | 40 | 93 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchiolitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| COVID-19 | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| Bronchitis viral | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| Device related infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| Medical device site infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| Neonatal infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| Pneumonia aspiration | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| Pneumonia viral | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| Septic shock | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| Wound infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| Apnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Bronchopulmonary dysplasia | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Choking | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Apnoeic attack | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Chronic respiratory disease | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Inguinal hernia | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Anaesthetic complication pulmonary | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
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| Postoperative respiratory distress | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
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| Poor feeding infant | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
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| Overfeeding of infant | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
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| Lethargy | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
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| Partial seizures | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
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| Seizure | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
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| Cardiac failure acute | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
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| Multiple organ dysfunction syndrome | General disorders | MedDRA 25.0 | Systematic Assessment |
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| Device malfunction | Product Issues | MedDRA 25.0 | Systematic Assessment |
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| Prophylaxis against dehydration | Surgical and medical procedures | MedDRA 25.0 | Systematic Assessment |
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| Removal of foreign body from gastrointestinal tract | Surgical and medical procedures | MedDRA 25.0 | Systematic Assessment |
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| Oxygen saturation decreased | Investigations | MedDRA 25.0 | Systematic Assessment |
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| Retinal detachment Study Eye | Eye disorders | MedDRA 25.0 | Systematic Assessment |
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| Vitreous haemorrhage Study Eye | Eye disorders | MedDRA 25.0 | Systematic Assessment |
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| Atrophy of globe Study Eye | Eye disorders | MedDRA 25.0 | Systematic Assessment |
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| Maculopathy Study Eye | Eye disorders | MedDRA 25.0 | Systematic Assessment |
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| Corneal infiltrates Study Eye | Eye disorders | MedDRA 25.0 | Systematic Assessment |
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| Retinal scar Study Eye | Eye disorders | MedDRA 25.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Inguinal hernia | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Umbilical hernia | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 25.0 | Systematic Assessment |
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| Bacterial disease carrier | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| Osteopenia | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
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| Apnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Bronchopulmonary dysplasia | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
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| Conjunctival haemorrhage Study Eye | Eye disorders | MedDRA 25.0 | Systematic Assessment |
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| Strabismus Study Eye | Eye disorders | MedDRA 25.0 | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA 25.0 | Systematic Assessment |
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The investigator has the right to independently publish study results from the investigator's site after a multi-center publication, or a defined period after the completion of the study by all sites. The investigator must provide the sponsor a copy of any such publication derived from the study for review and comment in advance of any submission, and delay publication, if requested, to allow the Sponsor to preserve its proprietary rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Administrator | Regeneron Pharmaceuticals, Inc. | 844-734-6643 | clinicaltrials@regeneron.com |
| Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 7, 2021 | Jun 12, 2023 | SAP_003.pdf |
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| ID | Term |
|---|---|
| D012178 | Retinopathy of Prematurity |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D007235 | Infant, Premature, Diseases |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
Not provided
Not provided
| ID | Term |
|---|---|
| C533178 | aflibercept |
Not provided
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Not provided
| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Black or African American |
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| Asian |
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| American Indian or Alaska Native |
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| Native Hawaiian or Other Pacific Islander |
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| Other |
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| Not Reported |
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| Zone II |
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