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Bevacizumab Eliminates the Angiogenic Threat of Retinopathy of Prematurity (BEAT-ROP)
This study is currently recruiting participants.
Verified by The University of Texas Health Science Center, Houston, January 2009
Sponsored by: The University of Texas Health Science Center, Houston
Information provided by: The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT00622726
  Purpose

This study will determine whether injections into the vitreous of an anti-vascular endothelial growth factor (VEGF) will reduce the incidence of blindness by suppressing the neovascular phase of retinopathy of prematurity (ROP) compared to a control group receiving conventional laser therapy. The purpose of this study is to determine the safety and efficacy of intravitreal bevacizumab in the treatment of ROP.


Condition Intervention Phase
Retinopathy of Prematurity
Drug: Bevacizumab
Procedure: Conventional Laser for ROP
Phase II

MedlinePlus related topics: Retinal Disorders
Drug Information available for: Bevacizumab Immunoglobulins Globulin, Immune
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Intravitreal Bevacizumab (AvastinTM) Injections Versus Conventional Laser Surgery for Vision-Threatening Retinopathy of Prematurity: a Prospective, Randomized, Non-Blinded, Controlled, Multi-Center, Clinical Trial

Further study details as provided by The University of Texas Health Science Center, Houston:

Primary Outcome Measures:
  • Success: Retinopathy of Prematurity (Zone I or Posterior II (Stage 3) has not recurred following treatment: Intravitreal Bevacizumab versus Laser Therapy [ Time Frame: 54 weeks adjusted age (6 to 7.5 months of age) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Determination of visual acuity, visual field, refraction, motility examination or any other ocular parameter related to severe ROP [ Time Frame: 80 weeks adjusted age (12 to 13.5 months of age) ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 150
Study Start Date: May 2008
Estimated Study Completion Date: October 2010
Estimated Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Bevacizumab for ROP: Experimental
Intravitreal Bevacizumab Therapy is the Experimental Arm of this Study
Drug: Bevacizumab
Anti-angiogenic drug: intravitreal injection of 0.625 mg (0.025 ml) once into each eye.
Conventional Laser for ROP: Active Comparator
Conventional Laser to the Peripheral Retina is the Control Arm of this Study
Procedure: Conventional Laser for ROP
Conventional Laser is applied to the Avascular Peripheral Retina (Anterior to the Vascularized Posterior Retina)

Detailed Description:

This phase 2 study will assess the anti-neovascularization activity of intravitreal bevacizumab, as determined by regression of neovascular vessels of retinopathy of prematurity (ROP), in neonates with acute stage 3 ROP in zone I or posterior zone II with plus disease. This study will enroll confirmed cases of vision threatening ROP (between ETROP and CRYO-ROP) which have definite plus disease. This will be done because of the controversy regarding determining plus disease and the increasing concern that many infants are being treated whose ROP would spontaneously regress. Bevacizumab will be administered intravitreally using 0.625 mg (0.025 ml) injections into each eye. There is no intent to give additional doses unless there is a recurrence of vision threatening stage 3 ROP with plus disease since the disease is self limited by completion of vascularization. Clinical response and any evidence of ocular toxicities will be documented both pre- and post-injection by RetCam retinal images and by fluorescein angiography when possible (structural documentation) and at 6 and 12 months of age by electroretinograms and by visual evoked potentials when possible (functional documentation). Any evidence of systemic toxicities will be documented by appropriate clinical and laboratory tests.

  Eligibility

Ages Eligible for Study:   up to 22 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Infants who have been screened by the AAO, AAP, and the AAPOS guidelines (≤1500 grams at birth and ≤30 weeks gestation) who develop Stage 3 ROP in zone I or posterior zone II.
  2. Informed Consent from a parent or guardian.

Exclusion Criteria:

  1. Infants who have a congenital systemic anomaly or have a congenital ocular abnormality.
  2. Infants who cannot be treated by conventional laser therapy because of problems with media clarity. Generally, blind external cryotherapy would be utilized as an initial therapy and the infant would be excluded from the study even if the media clear subsequently.
  3. Informed Consent from a parent or guardian refused. This will mean that an infant automatically will receive laser therapy. Bevacizumab (Avastin®) treatment cannot be given outside of the Protocol. No data will be used from an infant without Informed Consent.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00622726

Contacts
Contact: Helen A. Mintz-Hittner, M.D. 713-704-2345 Helen.A.Mintz-Hittner@uth.tmc.edu
Contact: Kathleen A. Kennedy, M.D., M.P.H. 713-500-6708 Kathleen.A.Kennedy@uth.tmc.edu

Locations
United States, California
Huntington Memorial Hospital Recruiting
Pasadena, California, United States, 91109
Contact: Ricardo L. Liberman, M.D.     818-216-5049     Ricardo_Liberman@Pediatrix.com    
Contact: Khaled A. Tawansy, M.D.     323-257-3937     ktawansy@sbcglobal.net    
Principal Investigator: Ricardo L. Liberman, M.D.            
Sub-Investigator: Khaled A. Tawansy, M.D.            
United States, Colorado
Presbyterian-St. Luke's Hospital Recruiting
Denver, Colorado, United States, 80218
Contact: Robert A. King, M.D.     303-456-9456     rking@cepcolorado.com    
Contact: Delphine M. Eichorst, M.D.     303-839-7740     Delphine_Eichorst@Pediatrix.com    
Principal Investigator: Robert A. King, M.D.            
Sub-Investigator: Delphine M. Eichorst, M.D.            
United States, Illinois
OSF St. Francis Medical Center-Children's Hospital of Illinois Recruiting
Peoria, Illinois, United States, 61637
Contact: Steven J. Lichtenstein, M.D.     309-243-2400 ext 3808     slichtenstein@illinoiseyecenter.com    
Contact: James R. Hocker, M.D.     309-655-2508     James.R.Hocker@osfhealthcare.org    
Principal Investigator: Steven J. Lichtenstein, M.D.            
Sub-Investigator: Parashos A. Lagouros, M.D.            
Sub-Investigator: James R. Hocker, M.D.            
University of Illinois at Chicago Recruiting
Chicago, Illinois, United States, 60612
Contact: Michael P. Blair, M.D.     312-996-0484     mblair2@uic.edu    
Contact: Rama Bhat, M.D.     312-996-4182     ramabhat@uic.edu    
Principal Investigator: Michael P. Blair, M.D.            
Sub-Investigator: Rama Bhat, M.D.            
United States, Indiana
Memorial Hospital Recruiting
South Bend, Indiana, United States, 46601
Contact: Robert D. White, M.D.     574-647-7351     Robert_White@Pediatrix.com    
Contact: Thomas L. Hauch, M.D.     574-233-3711     tlh2912@aol.com    
Principal Investigator: Robert D. White, M.D.            
Sub-Investigator: Thomas L. Hauch, M.D.            
United States, South Carolina
Palmetto Health Richland Hospital Recruiting
Columbia, South Carolina, United States, 29203
Contact: Lloyd Clark, M.D.     803-931-0077     LClark@palmettoretina.com    
Contact: Victor N. Iskersky, M.D.     803-434-6038     Victor_Iskersky@Pediatrix.com    
Principal Investigator: Lloyd Clark, M.D.            
Sub-Investigator: Victor N. Iskersky, M.D.            
Palmetto Health Baptist Hospital Recruiting
Columbia, South Carolina, United States, 29223
Contact: Lloyd Clark, M.D.     803-931-0077     LClark@palmettoretina.com    
Contact: Sharon S. Ellis, M.D.     803-296-5709     neon8l1@aol.com    
Principal Investigator: Lloyd Clark, M.D.            
Sub-Investigator: Sharon S. Ellis, M.D.            
United States, Texas
Driscoll Children's Hospital Recruiting
Corpus Christi, Texas, United States, 78411
Contact: Helen A. Mintz-Hittner, M.D.     713-704-2345     Helen.A.Mintz-Hittner@uth.tmc.edu    
Contact: Patricia L. Ramsay, M.D., Ph.D.     361-694-5335     Pat_Ramsay@Pediatrix.com    
Principal Investigator: Helen A. Mintz-Hittner, M.D.            
Sub-Investigator: Patricia L. Ramsay, M.D., Ph.D.            
Clear Lake Regional Medical Center Recruiting
Webster, Texas, United States, 77598
Contact: Helen A. Mintz-Hittner, M.D.     713-704-2345     Helen.A.Mintz-Hittner@uth.tmc.edu    
Contact: Harvinder S. Bedi, M.D.     281-338-3900     neonat@aol.com    
Principal Investigator: Helen A. Mintz-Hittner, M.D.            
Sub-Investigator: Harvinder S. Bedi, M.D.            
Cook Children's Medical Center Recruiting
Fort Worth, Texas, United States, 76104
Contact: David M. Riley, M.D.     817-739-7045     eagledoc23@yahoo.com    
Contact: Michael G. Hunt, M.D.     817-878-5454     mhunt@pedieyes.com    
Principal Investigator: David M. Riley, M.D.            
Principal Investigator: Michael G. Hunt, M.D.            
Children's Memorial Hermann Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Helen A. Mintz-Hittner, M.D.     713-704-2345     Helen.A.Mintz-Hittner@uth.tmc.edu    
Contact: Sophia Tsakiri, M.D.     713-704-2500     Sophia.Tsakiri@uth.tmc.edu    
Principal Investigator: Helen A. Mintz-Hittner, M.D.            
Sub-Investigator: Sophia Tsakiri, M.D.            
Memorial Hermann Southwest Hospital Recruiting
Houston, Texas, United States, 77074
Contact: Helen A. Mintz-Hittner, M.D.     713-704-2345     Helen.A.Mintz-Hittner@uth.tmc.edu    
Contact: Michelle Rhea, R.N.     713-456-5078     Michelle.Rhea@memorialhermann.org    
Principal Investigator: Helen A. Mintz-Hittner, M.D.            
Sub-Investigator: Syed H. Haider, M.D.            
Sub-Investigator: Zvi Friedman, M.D.            
Las Palmas Medical Center Recruiting
El Paso, Texas, United States, 79902
Contact: Helen A. Mintz-Hittner, M.D.     713-704-2345     Helen.A.Mintz-Hittner@uth.tmc.edu    
Contact: Luis A. Ayo, M.D.     915-449-0717     Olga_Delval@Pediatrix.com    
Principal Investigator: Helen A. Mintz-Hittner, M.D.            
Sub-Investigator: Luis A. Ayo, M.D.            
Del Sol Medical Center Recruiting
El Paso, Texas, United States, 79925
Contact: Helen A. Mintz-Hittner, M.D.     713-704-2345     Helen.A.Mintz-Hittner@uth.tmc.edu    
Contact: Enrique N. Ponte, M.D.     915-373-8285     eponte1@elp.rr.com    
Principal Investigator: Helen A. Mintz-Hittner, M.D.            
Sub-Investigator: Enrique N. Ponte, M.D.            
Providence Memorial Hospital Recruiting
El Paso, Texas, United States, 79902
Contact: Helen A. Mintz-Hittner, M.D.     713-704-2345     Helen.A.Mintz-Hittner@uth.tmc.edu    
Contact: Luis A. Ayo, M.D.     915-449-0717     Olga_Delval@Pediatrix.com    
Principal Investigator: Helen A. Mintz-Hittner, M.D.            
Sub-Investigator: Luis A. Ayo, M.D.            
R.E. Thomason Hospital Recruiting
El Paso, Texas, United States, 79905
Contact: Helen M. Mintz-Hittner, M.D.     713-704-2345     Helen.A.Mintz-Hittner@uth.tmc.edu    
Contact: Garrett S. Levin, M.D.     915-545-6776     garrett.levin@ttuhsc.edu    
Principal Investigator: Garrett S. Levin, M.D.            
Sub-Investigator: Violeta Radenovich, M.D., M.P.H.            
Baylor University Medical Center Recruiting
Dallas, Texas, United States, 75346
Contact: Craig T. Shoemaker, M.D.     214-820-7604     Craigs@BaylorHealth.edu    
Contact: Rand Spencer, M.D.     214-821-4540     rspencermd@mac.com    
Principal Investigator: Craig T. Shoemaker, M.D.            
Sub-Investigator: Rand Spencer, M.D.            
Valley Baptist Medical Center Recruiting
Brownsville, Texas, United States, 78520
Contact: Gerardo J. Sanchez, M.D.     956-698-5493     GJSanchezMD@hotmail.com    
Contact: Angela Kozak, D.O.     956-542-6945     akozzak@yahoo.com    
Principal Investigator: Gerardo J. Sanchez, M.D.            
Sub-Investigator: Angela Kozak, D.O.            
St. Joseph Medical Center Recruiting
Houston, Texas, United States, 77002
Contact: Helen A. Mintz-Hittner, M.D.     713-704-2345     Helen.A.Mintz-Hittner@uth.tmc.edu    
Contact: Elizabeth O'Donnell, M.D.     713-751-0794     Elizabeth_ODonnell@Pediatrix.com    
Principal Investigator: Helen A. Mintz-Hittner, M.D.            
Sub-Investigator: Elizabeth O'Donnell, M.D.            
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
Principal Investigator: Helen A. Mintz-Hittner, M.D. The University of Texas Health Science Center, Houston
  More Information

Publications:
Responsible Party: University of Texas Health Science Center-Houston ( Helen A. Mintz-Hittner, M.D. )
Study ID Numbers: HSC-MS-08-0036, IND: 101,578
Study First Received: February 13, 2008
Last Updated: January 5, 2009
ClinicalTrials.gov Identifier: NCT00622726  
Health Authority: United States: Food and Drug Administration

Keywords provided by The University of Texas Health Science Center, Houston:
Vascular Endothelial Growth Factor
Angiogenesis Inhibitor
Premature infants
Bevacizumab
Zone I or Posterior Zone II ROP
Aggressive Posterior ROP
Stage 3 ROP

Study placed in the following topic categories:
Antibodies, Monoclonal
Antibodies
Eye Diseases
Retinopathy of prematurity
Infant, Newborn, Diseases
Infant, Premature, Diseases
Retinopathy of Prematurity
Bevacizumab
Endothelial Growth Factors
Aggression
Retinal Diseases
Immunoglobulins

Additional relevant MeSH terms:
Antineoplastic Agents
Therapeutic Uses
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Angiogenesis Modulating Agents
Angiogenesis Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009