Bevacizumab Eliminates the Angiogenic Threat for Retinopathy of Prematurity

NCT00622726 | Unknown Phase 2 Results DMC

• 2 other identifiers: HSC-MS-08-0036IND: 101,578
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 15

Brief Summary

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.

Conditions

Retinopathy of Prematurity

Keywords

Vascular Endothelial Growth Factor; Angiogenesis Inhibitor; Premature infants; Bevacizumab; Zone I or Posterior Zone II ROP; Aggressive Posterior ROP; Stage 3 ROP; Neonatal Intensive Care Unit

Outcome Measures

Primary Outcomes (1)

• Number of Eyes Showing Recurrence of Neovascularization Arising From the Retinal Vessels and Requiring Re-treatment

  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).

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

Secondary Outcomes (2)

• Myopia in Zone I and Posterior Zone II of Infant Eyes

  2.5 years of age

• Visual Acuity

  Age 7 years.

Study Arms (2)

Bevacizumab for ROP

EXPERIMENTAL

Intravitreal Bevacizumab Therapy is the Experimental Arm of this Study

Drug: Bevacizumab

Conventional Laser for ROP

ACTIVE COMPARATOR

Conventional Laser to the Peripheral Retina is the Control Arm of this Study

Procedure: Conventional Laser for ROP

Interventions

Bevacizumab DRUG

Anti-angiogenic drug: intravitreal injection of 0.625 mg (0.025 ml) once into each eye.

Also known as: Avastin; Monoclonal antibody

Bevacizumab for ROP

Conventional Laser for ROP PROCEDURE

Conventional Laser is applied to the Avascular Peripheral Retina (Anterior to the Vascularized Posterior Retina)

Also known as: Diode Laser is the laser utilized for this study

Conventional Laser for ROP

Eligibility Criteria

• Age: 4 Weeks - 22 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Infants who have been screened by the American Academy of Ophthalmology, the American Academy of Pediatrics, and the 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.
• Informed Consent from a parent or guardian.

You may not qualify if:

• Infants who have a congenital systemic anomaly or have a congenital ocular abnormality.
• 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.
• 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.

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (15)

Huntington Memorial Hospital

Pasadena, California, 91109, United States

Location

Presbyterian-St. Luke's Hospital

Denver, Colorado, 80218, United States

Location

OSF St. Francis Medical Center-Children's Hospital of Illinois

Peoria, Illinois, 61637, United States

Location

Palmetto Health Richland Hospital

Columbia, South Carolina, 29203, United States

Location

Palmetto Health Baptist Hospital

Columbia, South Carolina, 29223, United States

Location

Driscoll Children's Hospital

Corpus Christi, Texas, 78411, United States

Location

Baylor University Medical Center

Dallas, Texas, 75346, United States

Location

Las Palmas Medical Center

El Paso, Texas, 79902, United States

Location

R.E. Thomason Hospital

El Paso, Texas, 79905, United States

Location

Del Sol Medical Center

El Paso, Texas, 79925, United States

Location

Cook Children's Medical Center

Fort Worth, Texas, 76104, United States

Location

St. Joseph Medical Center

Houston, Texas, 77002, United States

Location

Children's Memorial Hermann Hospital

Houston, Texas, 77030, United States

Location

Memorial Hermann Southwest Hospital

Houston, Texas, 77074, United States

Location

Clear Lake Regional Medical Center

Webster, Texas, 77598, United States

Location

Related Publications (9)

• Mintz-Hittner HA, Best LM. Antivascular endothelial growth factor for retinopathy of prematurity. Curr Opin Pediatr. 2009 Apr;21(2):182-7. doi: 10.1097/MOP.0b013e32832925f9.

  PMID: 19300261 BACKGROUND

• Mintz-Hittner HA. Avastin as monotherapy for retinopathy of prematurity. J AAPOS. 2010 Feb;14(1):2-3. doi: 10.1016/j.jaapos.2009.12.002. No abstract available.

  PMID: 20227612 BACKGROUND

• Mintz-Hittner HA. Intravitreal pegaptanib as adjunctive treatment for stage 3+ ROP shown to be effective in a prospective, randomized, controlled multicenter clinical trial. Eur J Ophthalmol. 2012 Sep-Oct;22(5):685-6. doi: 10.5301/ejo.5000176.

  PMID: 22669847 BACKGROUND

• Mintz-Hittner HA. Treatment of retinopathy of prematurity with vascular endothelial growth factor inhibitors. Early Hum Dev. 2012 Dec;88(12):937-41. doi: 10.1016/j.earlhumdev.2012.09.019. Epub 2012 Oct 15.

  PMID: 23078830 BACKGROUND

• Mintz-Hittner HA, Kuffel RR Jr. Intravitreal injection of bevacizumab (avastin) for treatment of stage 3 retinopathy of prematurity in zone I or posterior zone II. Retina. 2008 Jun;28(6):831-8. doi: 10.1097/IAE.0b013e318177f934.

  PMID: 18536599 RESULT

• Kong L, Mintz-Hittner HA, Penland RL, Kretzer FL, Chevez-Barrios P. Intravitreous bevacizumab as anti-vascular endothelial growth factor therapy for retinopathy of prematurity: a morphologic study. Arch Ophthalmol. 2008 Aug;126(8):1161-3. doi: 10.1001/archophthalmol.2008.1. No abstract available.

  PMID: 18695118 RESULT

• Mintz-Hittner HA, Kennedy KA, Chuang AZ; BEAT-ROP Cooperative Group. Efficacy of intravitreal bevacizumab for stage 3+ retinopathy of prematurity. N Engl J Med. 2011 Feb 17;364(7):603-15. doi: 10.1056/NEJMoa1007374.

  PMID: 21323540 RESULT

• Geloneck MM, Chuang AZ, Clark WL, Hunt MG, Norman AA, Packwood EA, Tawansy KA, Mintz-Hittner HA; BEAT-ROP Cooperative Group. Refractive outcomes following bevacizumab monotherapy compared with conventional laser treatment: a randomized clinical trial. JAMA Ophthalmol. 2014 Nov;132(11):1327-33. doi: 10.1001/jamaophthalmol.2014.2772.

  PMID: 25103848 RESULT

• Mintz-Hittner HA, Geloneck MM, Chuang AZ. Clinical Management of Recurrent Retinopathy of Prematurity after Intravitreal Bevacizumab Monotherapy. Ophthalmology. 2016 Sep;123(9):1845-55. doi: 10.1016/j.ophtha.2016.04.028. Epub 2016 May 27.

  PMID: 27241619 RESULT

MeSH Terms

Conditions

Retinopathy of Prematurity; Premature Birth

Interventions

Bevacizumab; Antibodies, Monoclonal

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Limitations and Caveats

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.

Results Point of Contact

• Title: Helen Mintz-Hittner, M.D.
• Organization: University of Texas Health Science Center-Houston

Helen.A.Mintz-Hittner@uth.tmc.edu

713-559-5277

Study Officials

• Helen A. Mintz-Hittner, M.D.

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor - Pediatric Ophthalmology

Study Record Dates

• First Submitted: February 13, 2008
• First Posted: February 25, 2008
• Study Start: March 1, 2008
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2020
• Last Updated: June 6, 2017
• Results First Posted: June 9, 2014

Record last verified: 2017-05

Locations

US (15)