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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Helen Mintz-Hittner, MD, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT00622726
First received: February 13, 2008
Last updated: May 8, 2014
Last verified: May 2014
  Purpose

The purpose of this study was to determine the efficacy and additional advantages of intravitreal bevacizumab in the treatment of ROP for both Zone I and Zone II Posterior.


Condition Intervention Phase
Retinopathy of Prematurity
Drug: Bevacizumab
Procedure: Conventional Laser for ROP
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Number of Eyes Showing Recurrence of Neovascularization Arising From the Retinal Vessels and Requiring Re-treatment [ Time Frame: 54 weeks postmenstrual age (window of 50 to 70 weeks) ] [ Designated as safety issue: No ]

    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).



Secondary Outcome Measures:
  • Number of Eyes Showing Very High Myopia [ Time Frame: 2.5 years of age ] [ Designated as safety issue: No ]
    Myopia was determined via refraction using a retinoscope and lenses. Very high myopia is defined as a refractice error greater than or equal to -8 diopters.

  • Visual Acuity [ Time Frame: Age 7 years. ] [ Designated as safety issue: No ]
    The visual acuity will be measured at 20 feet with figures or letters from all infants able to cooperate.


Enrollment: 150
Study Start Date: March 2008
Estimated Study Completion Date: May 2017
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bevacizumab for ROP
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.
Other Name: Avastin; Monoclonal antibody
Active Comparator: Conventional Laser for ROP
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)
Other Name: Diode Laser is the laser utilized for this study

Detailed Description:

This phase 2 study assessed 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 enrolled 150 confirmed cases of vision threatening ROP which have definite plus disease [ranging from ETROP, i.e., Early Treatment for Retinopathy of Prematurity, to CRYO-ROP, i.e., Cryotherapy for Retinopathy of Prematurity . This was 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 was no intent to give additional doses unless there was 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 were documented by Clarity Medical Systems, Inc. RetCam retinal imaging system taken pre-injection, one week and one month post injection, and at 6 months of age (54 weeks postmenstrual age)(window of 50 to 70 weeks PMA)(primary outcome) and at 12 months of age (80 weeks postmenstrual age)(window of 75 to 100 weeks PMA)(structural documentation). RetCam fluorescein angiograms have been taken when possible to document structural outcomes in greater detail. No evidence of systemic toxicities were 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, i.e., American Academy of Ophthalmology; the AAP, i.e., American Academy of Pediatrics; and the AAPOS, i.e., American Association for Pediatric Ophthalmology and Strabismus 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00622726

Locations
United States, California
Huntington Memorial Hospital
Pasadena, California, United States, 91109
United States, Colorado
Presbyterian-St. Luke's Hospital
Denver, Colorado, United States, 80218
United States, Illinois
OSF St. Francis Medical Center-Children's Hospital of Illinois
Peoria, Illinois, United States, 61637
United States, South Carolina
Palmetto Health Richland Hospital
Columbia, South Carolina, United States, 29203
Palmetto Health Baptist Hospital
Columbia, South Carolina, United States, 29223
United States, Texas
Driscoll Children's Hospital
Corpus Christi, Texas, United States, 78411
Baylor University Medical Center
Dallas, Texas, United States, 75346
R.E. Thomason Hospital
El Paso, Texas, United States, 79905
Del Sol Medical Center
El Paso, Texas, United States, 79925
Las Palmas Medical Center
El Paso, Texas, United States, 79902
Cook Children's Medical Center
Fort Worth, Texas, United States, 76104
Memorial Hermann Southwest Hospital
Houston, Texas, United States, 77074
Children's Memorial Hermann Hospital
Houston, Texas, United States, 77030
St. Joseph Medical Center
Houston, Texas, United States, 77002
Clear Lake Regional Medical Center
Webster, Texas, United States, 77598
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: Helen Mintz-Hittner, MD, Clinical Professor - Ophthalmology, 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
Study First Received: February 13, 2008
Results First Received: May 8, 2013
Last Updated: May 8, 2014
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

Additional relevant MeSH terms:
Retinal Diseases
Retinopathy of Prematurity
Eye Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 30, 2014