Trial Outcomes & Findings for Bevacizumab Eliminates the Angiogenic Threat for Retinopathy of Prematurity (NCT NCT00622726)

Results Overview

For Bevacizumab: Regrowth of new vessels at the site of the original extraretinal fibrovascular proliferation and/or at the site of the anterior edge of inner retinal vascularization. For Laser: Regrowth of new vessels from the vessels at the anterior edge of inner retinal vascularization (remaining after retinal ablation).

Recruitment status

UNKNOWN

Study phase

PHASE2

Target enrollment

150 participants

Primary outcome timeframe

54 weeks postmenstrual age (window of 50 to 70 weeks)

Results posted on

2017-06-06

Participant Flow

Dates of recruitment: March 13, 2008 to August 4, 2010. Patients recruited were all in neonatal intensive care units.

Participant milestones

Participant milestones
Measure	Bevacizumab for ROP-Experimental Arm Intravitreal Bevacizumab Therapy is the Experimental Arm of this Study. 31 patients had zone I ROP; 39 patients had zone II posterior ROP.	Conventional Laser for ROP-Control Arm Conventional Laser to the Peripheral Retina is the Control Arm of this Study. 33 patients had zone I ROP; 40 patients had posterior zone II ROP.
March, 2008 to August, 2010 STARTED	75	75
March, 2008 to August, 2010 COMPLETED	70	73
March, 2008 to August, 2010 NOT COMPLETED	5	2
August, 2010 to April, 2013 STARTED	70	73
August, 2010 to April, 2013 COMPLETED	69	68
August, 2010 to April, 2013 NOT COMPLETED	1	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Bevacizumab for ROP-Experimental Arm Intravitreal Bevacizumab Therapy is the Experimental Arm of this Study. 31 patients had zone I ROP; 39 patients had zone II posterior ROP.	Conventional Laser for ROP-Control Arm Conventional Laser to the Peripheral Retina is the Control Arm of this Study. 33 patients had zone I ROP; 40 patients had posterior zone II ROP.
March, 2008 to August, 2010 Death	5	2
August, 2010 to April, 2013 Death	1	5

Baseline Characteristics

Bevacizumab Eliminates the Angiogenic Threat for Retinopathy of Prematurity

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Bevacizumab for ROP-Experimental Arm n=75 Participants Intravitreal Bevacizumab Therapy is the Experimental Arm of this Study. 31 patients had zone I ROP; 39 patients had zone II posterior ROP.	Conventional Laser for ROP-Control Arm n=75 Participants Conventional Laser to the Peripheral Retina is the Control Arm of this Study. 33 patients had zone I ROP; 40 patients had posterior zone II ROP.	Total n=150 Participants Total of all reporting groups
Age, Categorical <=18 years	75 Participants n=5 Participants	75 Participants n=7 Participants	150 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	0.2 years STANDARD_DEVIATION 0.1 • n=5 Participants	0.2 years STANDARD_DEVIATION 0.1 • n=7 Participants	0.2 years STANDARD_DEVIATION 0.1 • n=5 Participants
Sex: Female, Male Female	26 Participants n=5 Participants	23 Participants n=7 Participants	49 Participants n=5 Participants
Sex: Female, Male Male	49 Participants n=5 Participants	52 Participants n=7 Participants	101 Participants n=5 Participants
Region of Enrollment United States	75 participants n=5 Participants	75 participants n=7 Participants	150 participants n=5 Participants

PRIMARY outcome

Timeframe: 54 weeks postmenstrual age (window of 50 to 70 weeks)

Population: Both eyes of all surviving infants were analyzed for recurrence: thus, 143 surviving infants and 286 eyes were analyzed. Reporting the number of eyes that developed recurrences

For Bevacizumab: Regrowth of new vessels at the site of the original extraretinal fibrovascular proliferation and/or at the site of the anterior edge of inner retinal vascularization. For Laser: Regrowth of new vessels from the vessels at the anterior edge of inner retinal vascularization (remaining after retinal ablation).

Outcome measures

Outcome measures
Measure	Bevacizumab for ROP-Experimental Arm n=140 Eyes Intravitreal Bevacizumab Therapy is the Experimental Arm of this Study. 31 patients/62 eyes had zone I ROP; 39 patients/78 eyes had zone II posterior ROP.	Conventional Laser for ROP-Control Arm n=146 Eyes Conventional Laser to the Peripheral Retina is the Control Arm of this Study. 33 patients/66 eyes had zone I ROP; 40 patients/80 eyes had posterior zone II ROP.	Bevacizumab Experimental Group: Posterior Zone II The eyes of all surviving infants without recurrences and without any previous intra-ocular surgery who received bevacizumab will be examined: Posterior Zone II.	Conventional Laser-Control Group: Posterior Zone II The eyes of all surviving infants without recurrences and without any previous intra-ocular surgery who received conventional laser will be examined: Posterior Zone II.
Number of Eyes Showing Recurrence of Neovascularization Arising From the Retinal Vessels and Requiring Re-treatment	6 eyes with recurrences	32 eyes with recurrences	—	—

SECONDARY outcome

Timeframe: 2.5 years of age

Population: As of 6/2013, there were 13 deaths/ 26 eyes. Exclusions from surviving 137 infants/ 274 eyes: 6 infants/19 eyes with intraocular surgery--leaving: 131 infants/ 255 eyes; 14 infants/ 21 eyes had recurrence and 22 infants/ 44 eyes were lost to follow-up--leaving: 95 infants/ 190 eyes. Thus, only the refractions on these infants/ eyes are given.

Myopia was determined via refraction using a retinoscope and lenses. Myopia is defined as a refractive error reported in Diopters.

Outcome measures

Outcome measures
Measure	Bevacizumab for ROP-Experimental Arm n=25 Participants Intravitreal Bevacizumab Therapy is the Experimental Arm of this Study. 31 patients/62 eyes had zone I ROP; 39 patients/78 eyes had zone II posterior ROP.	Conventional Laser for ROP-Control Arm n=26 Eyes Conventional Laser to the Peripheral Retina is the Control Arm of this Study. 33 patients/66 eyes had zone I ROP; 40 patients/80 eyes had posterior zone II ROP.	Bevacizumab Experimental Group: Posterior Zone II n=56 Eyes The eyes of all surviving infants without recurrences and without any previous intra-ocular surgery who received bevacizumab will be examined: Posterior Zone II.	Conventional Laser-Control Group: Posterior Zone II n=58 Eyes The eyes of all surviving infants without recurrences and without any previous intra-ocular surgery who received conventional laser will be examined: Posterior Zone II.
Myopia in Zone I and Posterior Zone II of Infant Eyes	-1.36 Diopters Standard Deviation 3.34	-7.34 Diopters Standard Deviation 7.44	-0.63 Diopters Standard Deviation 2.56	-5.20 Diopters Standard Deviation 5.77

SECONDARY outcome

Timeframe: Age 7 years.

The visual acuity will be measured at 20 feet with figures or letters from all infants able to cooperate.

Outcome measures

Outcome data not reported

Adverse Events

Bevacizumab for ROP-Experimental Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Conventional Laser for ROP-Control Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Helen Mintz-Hittner, M.D.

University of Texas Health Science Center-Houston

Phone: 713-559-5277

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place