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Trial record 42 of 293 for:    retinopathy of prematurity

Bevacizumab Eliminates the Angiogenic Threat for Retinopathy of Prematurity (BEAT-ROP)

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ClinicalTrials.gov Identifier: NCT00622726
Recruitment Status : Active, not recruiting
First Posted : February 25, 2008
Results First Posted : June 9, 2014
Last Update Posted : June 6, 2017
Sponsor:
Information provided by (Responsible Party):
Helen Mintz-Hittner, MD, The University of Texas Health Science Center, Houston

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Retinopathy of Prematurity
Interventions Drug: Bevacizumab
Procedure: Conventional Laser for ROP
Enrollment 150
Recruitment Details Dates of recruitment: March 13, 2008 to August 4, 2010. Patients recruited were all in neonatal intensive care units.
Pre-assignment Details  
Arm/Group Title Bevacizumab for ROP-Experimental Arm Conventional Laser for ROP-Control Arm
Hide Arm/Group Description 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 to the Peripheral Retina is the Control Arm of this Study. 33 patients had zone I ROP; 40 patients had posterior zone II ROP.
Period Title: March, 2008 to August, 2010
Started 75 75
Completed 70 [1] 73 [1]
Not Completed 5 2
Reason Not Completed
Death             5             2
[1]
All infants were extremely immature with multiple neonatal intensive care unit complications.
Period Title: August, 2010 to April, 2013
Started 70 73
Completed 69 68
Not Completed 1 5
Reason Not Completed
Death             1             5
Arm/Group Title Bevacizumab for ROP-Experimental Arm Conventional Laser for ROP-Control Arm Total
Hide Arm/Group Description 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 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 of all reporting groups
Overall Number of Baseline Participants 75 75 150
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 75 participants 75 participants 150 participants
<=18 years
75
 100.0%
75
 100.0%
150
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 75 participants 75 participants 150 participants
0.2  (0.1) 0.2  (0.1) 0.2  (0.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 75 participants 75 participants 150 participants
Female
26
  34.7%
23
  30.7%
49
  32.7%
Male
49
  65.3%
52
  69.3%
101
  67.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 75 participants 75 participants 150 participants
75 75 150
1.Primary Outcome
Title Number of Eyes Showing Recurrence of Neovascularization Arising From the Retinal Vessels and Requiring Re-treatment
Hide Description

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).

Time Frame 54 weeks postmenstrual age (window of 50 to 70 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Bevacizumab for ROP-Experimental Arm Conventional Laser for ROP-Control Arm
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 70 73
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
140 146
Measure Type: Number
Unit of Measure: eyes with recurrences
6 32
2.Secondary Outcome
Title Myopia in Zone I and Posterior Zone II of Infant Eyes
Hide Description Myopia was determined via refraction using a retinoscope and lenses. Myopia is defined as a refractive error reported in Diopters.
Time Frame 2.5 years of age
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Bevacizumab-Experimental Group: Zone I Conventional Laser-Control Group: Zone I Bevacizumab Experimental Group: Posterior Zone II Conventional Laser-Control Group: Posterior Zone II
Hide Arm/Group Description:
The eyes of all surviving infants without recurrences and without any previous intra-ocular surgery who received bevacizumab will be examined: Zone I.
The eyes of all surviving infants without recurrences and without any previous intra-ocular surgery who received conventional laser will be examined: Zone I.
The eyes of all surviving infants without recurrences and without any previous intra-ocular surgery who received bevacizumab will be examined: 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.
Overall Number of Participants Analyzed 25 12 28 30
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
50 26 56 58
Mean (Standard Deviation)
Unit of Measure: Diopters
-1.36  (3.34) -7.34  (7.44) -0.63  (2.56) -5.20  (5.77)
3.Secondary Outcome
Title Visual Acuity
Hide Description The visual acuity will be measured at 20 feet with figures or letters from all infants able to cooperate.
Time Frame Age 7 years.
Outcome Measure Data Not Reported
Time Frame March, 2008 to April 2013
Adverse Event Reporting Description No adverse events have occurred (with the exception of 6 deaths in the bevacizumab arm and 7 deaths in the conventional laser arm.
 
Arm/Group Title Bevacizumab for ROP-Experimental Arm Conventional Laser for ROP-Control Arm
Hide Arm/Group Description 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 to the Peripheral Retina is the Control Arm of this Study. 33 patients had zone I ROP; 40 patients had posterior zone II ROP.
All-Cause Mortality
Bevacizumab for ROP-Experimental Arm Conventional Laser for ROP-Control Arm
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Bevacizumab for ROP-Experimental Arm Conventional Laser for ROP-Control Arm
Affected / at Risk (%) Affected / at Risk (%)
Total   0/69 (0.00%)   0/68 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Bevacizumab for ROP-Experimental Arm Conventional Laser for ROP-Control Arm
Affected / at Risk (%) Affected / at Risk (%)
Total   0/69 (0.00%)   0/68 (0.00%) 

Limitations:

  1. number of patients is too small to determine efficacy of bevacizumab in posterior zone II ROP.
  2. number of patients is too small to determine safety of bevacizumab systemically.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Helen Mintz-Hittner, M.D.
Organization: University of Texas Health Science Center-Houston
Phone: 713-559-5277
Responsible Party: Helen Mintz-Hittner, MD, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT00622726     History of Changes
Other Study ID Numbers: HSC-MS-08-0036
IND: 101,578 ( Other Identifier: Research to Prevent Blindness (NY, NY) )
First Submitted: February 13, 2008
First Posted: February 25, 2008
Results First Submitted: May 8, 2013
Results First Posted: June 9, 2014
Last Update Posted: June 6, 2017