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Sponsored by: |
The University of Texas Health Science Center, Houston |
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Information provided by: | The University of Texas Health Science Center, Houston |
ClinicalTrials.gov Identifier: | NCT00622726 |
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 |
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Retinopathy of Prematurity |
Drug: Bevacizumab Procedure: Conventional Laser for ROP |
Phase II |
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 |
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 |
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Bevacizumab for ROP: Experimental
Intravitreal Bevacizumab Therapy is the Experimental Arm of this Study
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Drug: Bevacizumab
Anti-angiogenic drug: intravitreal injection of 0.625 mg (0.025 ml) once into each eye.
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Conventional Laser for ROP: Active Comparator
Conventional Laser to the Peripheral Retina is the Control Arm of this Study
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Procedure: Conventional Laser for ROP
Conventional Laser is applied to the Avascular Peripheral Retina (Anterior to the Vascularized Posterior Retina)
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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.
Ages Eligible for Study: | up to 22 Weeks |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
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. |
Principal Investigator: | Helen A. Mintz-Hittner, M.D. | The University of Texas Health Science Center, Houston |
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 |
Vascular Endothelial Growth Factor Angiogenesis Inhibitor Premature infants Bevacizumab |
Zone I or Posterior Zone II ROP Aggressive Posterior ROP Stage 3 ROP |
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 |
Antineoplastic Agents Therapeutic Uses Growth Substances Physiological Effects of Drugs |
Growth Inhibitors Angiogenesis Modulating Agents Angiogenesis Inhibitors Pharmacologic Actions |