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| ID | Type | Description | Link |
|---|---|---|---|
| UG1EY011751 | U.S. NIH Grant/Contract | View source |
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Lack of feasibility to recruit.
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| Name | Class |
|---|---|
| Pediatric Eye Disease Investigator Group | NETWORK |
| National Eye Institute (NEI) | NIH |
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This randomized clinical trial will compare retinal outcomes with low-dose intravitreous bevacizumab (0.063 mg) versus laser photocoagulation as treatment for infants with type 1 retinopathy of prematurity (ROP).
The study also will assess neurodevelopment, refractive error, visual acuity, and peripheral visual fields.
Infants with type 1 ROP and no prior treatment for ROP will be randomly assigned (1:1) to treatment with either intravitreous bevacizumab 0.063 mg or peripheral retinal laser ablation. Study exams will be at weeks 1, 2, and 4 weeks, and at 2 and 4-months post-treatment (and re-treatment when indicated). Additional study exams will occur at adjusted age 6 months, 1 year, and then annually for 5 more years. Non-study examinations will be at clinician discretion and are likely to occur more often. The primary outcome will be treatment success, defined as no worsening of ROP 5-13 days after treatment (or re-treatment if indicated), no plus disease or severe neovascularization 2 weeks to 6 months after treatment (or re-treatment if indicated), and no unfavorable structural outcome (or prior scleral buckle or vitrectomy) at 6 months adjusted age. Important secondary outcomes include the number of re-treatments, extent of retinal vascularization, refractive error, neurodevelopment assessed by the Bayley-4 test, IQ and neuropsychiatric testing, visual acuity, visual fields, and systemic morbidities.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laser | Active Comparator | For infants randomized to laser treatment, it will be given in conjunction with a binocular indirect ophthalmoscope and an appropriate condensing lens, by a study-certified ophthalmologist experienced in the use of this equipment. The treating investigator will be certified as having sufficient experience with laser for ROP, and adequacy of laser treatment will be confirmed by expert review of photographs. Special laser precautions, as mandated by Occupational Safety and Health Administration (OSHA) and facility standards, will be followed. |
|
| Bevacizumab | Experimental | For infants randomized to bevacizumab, the Intravitreous bevacizumab 0.063 mg injection will be given no later than 2 days after the diagnosis of type 1 ROP. The ophthalmologist may choose to give the intravitreous injection in the operating room or at the bedside, with or without anesthesia, after consultation with the attending neonatologist. A binocular indirect ophthalmoscope with an appropriate condensing lens should be available, and the pupils should be dilated. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bevacizumab | Drug | For infants randomized to bevacizumab, the Intravitreous bevacizumab 0.063 mg injection will be given no later than 2 days after the diagnosis of type 1 ROP. The ophthalmologist may choose to give the intravitreous injection in the operating room or at the bedside, with or without anesthesia, after consultation with the attending neonatologist. A binocular indirect ophthalmoscope with an appropriate condensing lens should be available, and the pupils should be dilated. |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Success Rate At 6 Months Adjusted Age | The primary objective for the randomized trial is to determine if infants with type 1 ROP treated with intravitreal bevacizumab (subsequently referred to as BV) have a treatment success rate determined at 6 months adjusted age that is non-inferior compared with infants treated with laser photocoagulation (subsequently referred to as LASER). | 6 Months Adjusted Age |
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Inclusion Criteria:
Birth weight < 1251 grams
Newly diagnosed (within 2 days) type 1 ROP in one or both eyes; meeting the following criteria:
Exclusion Criteria:
One eye will be excluded, and other eye may be eligible, if either of the following are present:
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| Name | Affiliation | Role |
|---|---|---|
| David K Wallace, MD, MPH | Indiana University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizonia Pediatric Eye Specialists | Phoenix | Arizona | 85006 | United States | ||
| Arkansas Childrens Hospital/ University of Arkansas Medical Sciences |
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| Label | URL |
|---|---|
| PEDIG Public Website | View source |
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Yes In accordance with the NIH data sharing policy, a de-identified database is placed in the public domain on the Pediatric Eye Disease Investigator Group (PEDIG) public website after the completion of each protocol and publication of the primary manuscript.
Data will be made available after publication of each primary manuscript.
Users accessing the data must enter an email address.
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| ID | Title | Description |
|---|---|---|
| FG000 | Laser | For infants randomized to laser treatment, it will be given in conjunction with a binocular indirect ophthalmoscope and an appropriate condensing lens, by a study-certified ophthalmologist experienced in the use of this equipment. The treating investigator will be certified as having sufficient experience with laser for ROP, and adequacy of laser treatment will be confirmed by expert review of photographs. Special laser precautions, as mandated by Occupational Safety and Health Administration (OSHA) and facility standards, will be followed. Laser: For infants randomized to laser treatment, it will be given in conjunction with a binocular indirect ophthalmoscope and an appropriate condensing lens, by a study-certified ophthalmologist experienced in the use of this equipment. The treating investigator will be certified as having sufficient experience with laser for ROP, and adequacy of laser treatment will be confirmed by expert review of photographs. Special laser precautions, as mandated by OSHA and facility standards, will be followed. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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 | Apr 28, 2022 | Jul 18, 2022 |
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|
|
| Laser | Procedure | For infants randomized to laser treatment, it will be given in conjunction with a binocular indirect ophthalmoscope and an appropriate condensing lens, by a study-certified ophthalmologist experienced in the use of this equipment. The treating investigator will be certified as having sufficient experience with laser for ROP, and adequacy of laser treatment will be confirmed by expert review of photographs. Special laser precautions, as mandated by OSHA and facility standards, will be followed. |
|
| Little Rock |
| Arkansas |
| 72202 |
| United States |
| Univ of California, Irvine- Gavin Herbert Eye Institute | Irvine | California | 92697 | United States |
| University of California, Davis | Sacramento | California | 95817 | United States |
| University of California San Francisco Department of Ophthalmology | San Francisco | California | 94143 | United States |
| University of Colorado Health Sciences Center | Aurora | Colorado | 80045 | United States |
| Denver Health and Hospital Authority | Denver | Colorado | 80204 | United States |
| Connecticut Childrens Medical Center | Farmington | Connecticut | 06032 | United States |
| The Emory Eye Center | Atlanta | Georgia | 30322 | United States |
| Ann & Robert H. Lurie Children's Hospital of Chicago | Chicago | Illinois | 60611 | United States |
| U of Illinois at Chicago Eye and Ear Infirmary | Chicago | Illinois | 60612 | United States |
| University of Chicago | Hyde Park | Illinois | 60637 | United States |
| Indiana University School of Medicine | Indianapolis | Indiana | 46202 | United States |
| Riley Hospital for Children | Indianapolis | Indiana | 46202 | United States |
| UK Ophthalmology and Visual Sciences, The Eye Clinic | Lexington | Kentucky | 40508 | United States |
| Greater Baltimore Medical Center | Baltimore | Maryland | 21204-5809 | United States |
| Boston Children's Hospital | Boston | Massachusetts | 02215 | United States |
| University of Missouri- Columbia Mason Eye Institute | Columbia | Missouri | 65201 | United States |
| St. Louis University Ophthalmology | St Louis | Missouri | 63104 | United States |
| Children's Hospital & Medical Center | Omaha | Nebraska | 68114 | United States |
| New York Presbyterian David H Koch Center | New York | New York | 10065 | United States |
| University of North Carolina | Chapel Hill | North Carolina | 27599 | United States |
| Duke University Eye Center | Durham | North Carolina | 27710 | United States |
| Cincinnati Children's Hospital | Cincinnati | Ohio | 45229 | United States |
| Pediatric Ophthalmology Associates, Inc. | Columbus | Ohio | 43205 | United States |
| Casey Eye Institute | Portland | Oregon | 97239 | United States |
| UPMC Children's Eye Center of Children's Hospital of Pittsburgh | Pittsburgh | Pennsylvania | 15224 | United States |
| Storm Eye Institute | Mt. Pleasant | South Carolina | 29464 | United States |
| Texas Children's Hospital - Dept. Of Ophthalmology | Houston | Texas | 77030 | United States |
| The Woman's Hospital of Texas | Houston | Texas | 77054 | United States |
| University of Utah Moran Eye Center | Salt Lake City | Utah | 84132 | United States |
| Virginia Pediatric Eye Center | Norfolk | Virginia | 23502 | United States |
| IWK Health Centre | Halifax | Nova Scotia | B3K 6R8 | Canada |
| The Hospital for Sick Children | Toronto | Ontario | M5G 1X8 | Canada |
| CHU - Sainte-Justine | Montreal | Quebec | H3T 1C5 | Canada |
| FG001 | Bevacizumab | For infants randomized to bevacizumab, the Intravitreous bevacizumab 0.063 mg injection will be given no later than 2 days after the diagnosis of type 1 ROP. The ophthalmologist may choose to give the intravitreous injection in the operating room or at the bedside, with or without anesthesia, after consultation with the attending neonatologist. A binocular indirect ophthalmoscope with an appropriate condensing lens should be available, and the pupils should be dilated. Bevacizumab: For infants randomized to bevacizumab, the Intravitreous bevacizumab 0.063 mg injection will be given no later than 2 days after the diagnosis of type 1 ROP. The ophthalmologist may choose to give the intravitreous injection in the operating room or at the bedside, with or without anesthesia, after consultation with the attending neonatologist. A binocular indirect ophthalmoscope with an appropriate condensing lens should be available, and the pupils should be dilated. |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Bevacizumab | For infants randomized to bevacizumab, the Intravitreous bevacizumab 0.063 mg injection will be given no later than 2 days after the diagnosis of type 1 ROP. The ophthalmologist may choose to give the intravitreous injection in the operating room or at the bedside, with or without anesthesia, after consultation with the attending neonatologist. A binocular indirect ophthalmoscope with an appropriate condensing lens should be available, and the pupils should be dilated. Bevacizumab: For infants randomized to bevacizumab, the Intravitreous bevacizumab 0.063 mg injection will be given no later than 2 days after the diagnosis of type 1 ROP. The ophthalmologist may choose to give the intravitreous injection in the operating room or at the bedside, with or without anesthesia, after consultation with the attending neonatologist. A binocular indirect ophthalmoscope with an appropriate condensing lens should be available, and the pupils should be dilated. |
| BG001 | Laser | For infants randomized to laser treatment, it will be given in conjunction with a binocular indirect ophthalmoscope and an appropriate condensing lens, by a study-certified ophthalmologist experienced in the use of this equipment. The treating investigator will be certified as having sufficient experience with laser for ROP, and adequacy of laser treatment will be confirmed by expert review of photographs. Special laser precautions, as mandated by Occupational Safety and Health Administration (OSHA) and facility standards, will be followed. Laser: For infants randomized to laser treatment, it will be given in conjunction with a binocular indirect ophthalmoscope and an appropriate condensing lens, by a study-certified ophthalmologist experienced in the use of this equipment. The treating investigator will be certified as having sufficient experience with laser for ROP, and adequacy of laser treatment will be confirmed by expert review of photographs. Special laser precautions, as mandated by OSHA and facility standards, will be followed. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Gestational Age | Mean | Standard Deviation | weeks |
| ||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Birth Weight | Mean | Standard Deviation | grams |
|
| 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 | Treatment Success Rate At 6 Months Adjusted Age | The primary objective for the randomized trial is to determine if infants with type 1 ROP treated with intravitreal bevacizumab (subsequently referred to as BV) have a treatment success rate determined at 6 months adjusted age that is non-inferior compared with infants treated with laser photocoagulation (subsequently referred to as LASER). | Study terminated due to lack of feasibility of recruitment. No analyses conducted due to lack of power for analysis given small sample size. | Posted | Count of Participants | Participants | 6 Months Adjusted Age |
|
|
|
Adverse events were collected throughout the study until study completion, up to 1 year (terminated early).
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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 | Bevacizumab | For infants randomized to bevacizumab, the Intravitreous bevacizumab 0.063 mg injection will be given no later than 2 days after the diagnosis of type 1 ROP. The ophthalmologist may choose to give the intravitreous injection in the operating room or at the bedside, with or without anesthesia, after consultation with the attending neonatologist. A binocular indirect ophthalmoscope with an appropriate condensing lens should be available, and the pupils should be dilated. Bevacizumab: For infants randomized to bevacizumab, the Intravitreous bevacizumab 0.063 mg injection will be given no later than 2 days after the diagnosis of type 1 ROP. The ophthalmologist may choose to give the intravitreous injection in the operating room or at the bedside, with or without anesthesia, after consultation with the attending neonatologist. A binocular indirect ophthalmoscope with an appropriate condensing lens should be available, and the pupils should be dilated. | 0 | 7 | 1 | 7 | 4 | 7 |
| EG001 | Laser | For infants randomized to laser treatment, it will be given in conjunction with a binocular indirect ophthalmoscope and an appropriate condensing lens, by a study-certified ophthalmologist experienced in the use of this equipment. The treating investigator will be certified as having sufficient experience with laser for ROP, and adequacy of laser treatment will be confirmed by expert review of photographs. Special laser precautions, as mandated by Occupational Safety and Health Administration (OSHA) and facility standards, will be followed. Laser: For infants randomized to laser treatment, it will be given in conjunction with a binocular indirect ophthalmoscope and an appropriate condensing lens, by a study-certified ophthalmologist experienced in the use of this equipment. The treating investigator will be certified as having sufficient experience with laser for ROP, and adequacy of laser treatment will be confirmed by expert review of photographs. Special laser precautions, as mandated by OSHA and facility standards, will be followed. | 0 | 9 | 4 | 9 | 6 | 9 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eustachian tube dysfunction | Ear and labyrinth disorders | Systematic Assessment |
| ||
| Viral Syndrome | Infections and infestations | Systematic Assessment |
| ||
| Head Injury | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Failure to Thrive | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Cerebral Palsy | Nervous system disorders | Systematic Assessment |
| ||
| Hydrocephalus | Nervous system disorders | Systematic Assessment |
| ||
| Primary Apnea of premature newborns | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Respiratory Distress | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Respiratory infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Respiratory insufficiency | Reproductive system and breast disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Corneal edema | Eye disorders | Systematic Assessment |
| ||
| Esotropia | Eye disorders | Systematic Assessment |
| ||
| Myopia | Eye disorders | Systematic Assessment |
| ||
| Preretinal Hemorrhage | Eye disorders | Systematic Assessment |
| ||
| Retinal Hemorrhage | Eye disorders | Systematic Assessment |
| ||
| Bradycardia | Cardiac disorders | Systematic Assessment |
| ||
| Cardiac Arrhythmia | Cardiac disorders | Systematic Assessment |
| ||
| Bloody stool | Gastrointestinal disorders | Systematic Assessment |
| ||
| Electrolyte and fluid balance condition | General disorders | Systematic Assessment |
| ||
| COVID-19 | Infections and infestations | Systematic Assessment |
| ||
| Streptococcal infection NOS | Infections and infestations | Systematic Assessment |
| ||
| Thrush | Infections and infestations | Systematic Assessment |
| ||
| Viral Syndrome | Infections and infestations | Systematic Assessment |
| ||
| Oxygen Saturations Low | Investigations | Systematic Assessment |
| ||
| Fractured Ribs | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Osteopenia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Neurologic disorder NOS | Nervous system disorders | Systematic Assessment |
| ||
| Hypoxia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Primary apnea of premature newborns | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Tachypnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Skin Abrasion | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
Early termination leading to small numbers of subjects which precluded statistical analysis. Active participants were released from study at time of study termination.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ray Kraker | Jaeb Center for Health Research | 8139758690 | rkraker@jaeb.org |
| Prot_003.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 5, 2021 | Oct 12, 2021 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 27, 2022 | Jul 18, 2022 | ICF_004.pdf |
Not provided
| 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 |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| D007834 | Lasers |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D055618 | Radiation Equipment and Supplies |
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| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|