Clinical trial NCT04634604: A Randomized Trial of Low-Dose Bevacizumab vs Laser for Type 1 ROP
Official title: A Randomized Trial of Low-Dose Bevacizumab Versus Laser for Type 1 Retinopathy of Prematurity
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Retinopathy of Prematurity
Lead sponsor: Jaeb Center for Health Research
Sponsor class: OTHER
Collaborators: name: Pediatric Eye Disease Investigator Group
name: National Eye Institute (NEI)
First posted: 2020-11-18
Enrollment: 16
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Birth weight \< 1251 grams
* Newly diagnosed (within 2 days) type 1 ROP in one or both eyes; meeting the following criteria:

  * Zone I, any stage ROP with plus disease, with retinal vessels or ROP in Zone II in any quadrant, or
  * Zone I, stage 3 ROP without plus disease, with retinal vessels or ROP in zone II in any quadrant or
  * Zone II, stage 2 or 3 ROP with plus disease

Exclusion Criteria:

* Previous treatment for ROP
* Stage 4 or 5 ROP in either eye
* All ROP in zone I in either eye (no retinal vessels or ROP extend into zone II in any quadrant)
* Either treatment could not be done within 2 days of diagnosis of type 1 ROP
* Investigator unwilling to randomize or parent unwilling to accept random assignment to either treatment
* Transfer to another hospital not covered by study-certified examiners anticipated within the next 4 weeks
* Active ocular infection or purulent nasolacrimal duct obstruction in either eye

One eye will be excluded, and other eye may be eligible, if either of the following are present:

* Visually significant ocular anomaly (e.g., cataract, coloboma)
* Opacity that precludes an adequate view of the retina

Primary outcomes:
measure: Treatment Success Rate At 6 Months Adjusted Age
timeFrame: 6 Months Adjusted Age
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizonia Pediatric Eye Specialists
state: Arizona
city: Little Rock
country: United States
facility: Arkansas Childrens Hospital/ University of Arkansas Medical Sciences
state: Arkansas
city: Irvine
country: United States
facility: Univ of California, Irvine- Gavin Herbert Eye Institute
state: California
city: Sacramento
country: United States
facility: University of California, Davis
state: California
city: San Francisco
country: United States
facility: University of California San Francisco Department of Ophthalmology
state: California
city: Aurora
country: United States
facility: University of Colorado Health Sciences Center
state: Colorado
city: Denver
country: United States
facility: Denver Health and Hospital Authority
state: Colorado
city: Farmington
country: United States
facility: Connecticut Childrens Medical Center
state: Connecticut
city: Atlanta
country: United States
facility: The Emory Eye Center
state: Georgia
city: Chicago
country: United States
facility: Ann & Robert H. Lurie Children's Hospital of Chicago
state: Illinois
city: Chicago
country: United States
facility: U of Illinois at Chicago Eye and Ear Infirmary
state: Illinois
city: Hyde Park
country: United States
facility: University of Chicago
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University School of Medicine
state: Indiana
city: Indianapolis
country: United States
facility: Riley Hospital for Children
state: Indiana
city: Lexington
country: United States
facility: UK Ophthalmology and Visual Sciences, The Eye Clinic
state: Kentucky
city: Baltimore
country: United States
facility: Greater Baltimore Medical Center
state: Maryland
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
city: Columbia
country: United States
facility: University of Missouri- Columbia Mason Eye Institute
state: Missouri
city: Saint Louis
country: United States
facility: St. Louis University Ophthalmology
state: Missouri
city: Omaha
country: United States
facility: Children's Hospital & Medical Center
state: Nebraska
city: New York
country: United States
facility: New York Presbyterian David H Koch Center
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Durham
country: United States
facility: Duke University Eye Center
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital
state: Ohio
city: Columbus
country: United States
facility: Pediatric Ophthalmology Associates, Inc.
state: Ohio
city: Portland
country: United States
facility: Casey Eye Institute
state: Oregon
city: Pittsburgh
country: United States
facility: UPMC Children's Eye Center of Children's Hospital of Pittsburgh
state: Pennsylvania
city: Mount Pleasant
country: United States
facility: Storm Eye Institute
state: South Carolina
city: Houston
country: United States
facility: Texas Children's Hospital - Dept. Of Ophthalmology
state: Texas
city: Houston
country: United States
facility: The Woman's Hospital of Texas
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah Moran Eye Center
state: Utah
city: Norfolk
country: United States
facility: Virginia Pediatric Eye Center
state: Virginia
city: Halifax
country: Canada
facility: IWK Health Centre
state: Nova Scotia
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
city: Montreal
country: Canada
facility: CHU - Sainte-Justine
state: Quebec
Study officials:
affiliation: Indiana University
name: David K Wallace, MD, MPH
role: STUDY_CHAIR
References: