A Randomized Trial of Low-Dose Bevacizumab vs Laser for Type 1 ROP

Retinopathy of Prematurity Clinical Trial

— ROP3  

Official title:

A Randomized Trial of Low-Dose Bevacizumab Versus Laser for Type 1 Retinopathy of Prematurity

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04634604
• Other study ID #: ROP3
• Secondary ID: UG1EY011751
• Status: Terminated
• Phase: Phase 3
• Start date: April 27, 2022
• Est. completion date: August 14, 2023

Study information

• Verified date: November 2023
• Source: Jaeb Center for Health Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: August 14, 2023
• Est. primary completion date: August 14, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 6 Months

Eligibility

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

Related Conditions & MeSH terms

• Premature Birth
• Retinal Diseases
• Retinopathy of Prematurity

Intervention

Drug:
• 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.

Procedure:
• 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.

Locations

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

Sponsors (3)

Lead Sponsor	Collaborator
Jaeb Center for Health Research	National Eye Institute (NEI), Pediatric Eye Disease Investigator Group

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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).	6 Months Adjusted Age

External Links

•   PEDIG Public Website