Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Vision Research Foundation |
---|---|
Information provided by: | Vision Research Foundation |
ClinicalTrials.gov Identifier: | NCT00702819 |
Retinopathy of Prematurity (ROP) is a leading cause of blindness in children in developed countries around the world, and an increasing cause of blindness in developing countries.
The retina lines the inside of the eye. It functions as "film" within the camera which is the eye. When an infant is born prematurely, the vascular network necessary to nourish the retina has not fully developed. As a consequence, in some infants abnormal vessels proliferate instead of the normal ones - a condition known as ROP. The abnormal vessels carry scar tissue along with them, and may lead to retinal detachment and blindness if the eye is not treated.
The Multicenter Trial of Cryotherapy for Retinopathy of Prematurity (CRYO-ROP) Study demonstrated that ablation of the peripheral avascular retina reduced the risk of poor structural and visual outcome due to retinal distortion or detachment in ROP (1980's). The ablated retina is not functional and is not amenable to regeneration.
Peripheral retinal ablation is not universally effective in fostering regression of ROP. This is particularly true for an aggressive form of ROP (aggressive posterior ROP, or APROP) which typically afflicts profoundly premature and infirm neonates. In this subset of infants, progression of ROP to bilateral retinal detachment and blindness occurs despite timely and complete peripheral retinal laser ablation.
Rationale The development of ROP is largely dependent on vascular endothelial growth factor (VEGF). When an infant is born prematurely the relatively hyperoxic environment the baby is introduced to shuts down the production of VEGF. Retinal maturation is delayed. Subsequently, at a time when intraocular VEGF levels would normally be declining late in the third trimester of pregnancy, abnormally high levels of VEGF are seen due to large areas of avascular retina and associated tissue hypoxia.
The availability of FDA-approved drugs for anti-VEGF treatment renders it possible to treat such eyes off-label. Available drugs include pegaptanib sodium (Macugen) for partial blockage of VEGF-A, or drugs such as ranibizumab (Lucentis) and bevacizumab (Avastin), which cause complete blockage of VEGF-A.
As VEGF is required in the developing retina for normal angiogenesis, and our goal is not to penetrate tissue, but to block the excessive levels of VEGF trapped within the overlying vitreous which is responsible for the abnormal vasculature in ROP.
For purposes of this study we have chosen bevacizumab (Avastin), which will: a) attain complete blockage (vs. Macugen) of intravitreal VEGF-A, and; b) which is limited in its ability to penetrate tissues because it is a full antibody (vs. Lucentis, an antibody fragment specifically designed for better tissue penetration), and is more likely to restore VEGF homeostasis within the developing retina.
Condition | Intervention | Phase |
---|---|---|
Retinopathy of Prematurity |
Drug: Bevacizumab |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety Study |
Official Title: | Phase 1 Trial of Pan-VEGF Blockade for the Treatment of Retinopathy of Prematurity |
Estimated Enrollment: | 22 |
Study Start Date: | June 2008 |
Estimated Study Completion Date: | July 2009 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 30 Weeks to 36 Weeks |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Eligibility criteria
Inclusion Criteria:
Exclusion Criteria:
Contact: Michael T Trese, MD | 248-288-2280 | mgjt46@aol.com |
Contact: Antonio Capone Jr, MD | 248-288-2280 | acaponejr@yahoo.com |
United States, California | |
California Vitreoretinal Center | Not yet recruiting |
Menlo Park, California, United States, 94025 | |
Contact: Darius Moshfeghi, MD 650-323-0231 dariusm@stanford.edu | |
Principal Investigator: Darius Moshfeghi, MD | |
Jules Stein Eye Center | Recruiting |
Los Angeles, California, United States, 90095 | |
Contact: Steven D Schwartz, MD 310-206-7474 schwartz@jsei.ucla.edu | |
Contact: Natalee Feduke 310-794-5596 feduke@jsei.ucla.edu | |
Principal Investigator: Steven Schwartz, MD | |
Childrens Hospital | Recruiting |
Los Angeles, California, United States, 90027 | |
Contact: Thomas Lee, MD 323-361-2299 thlee@chla.usc.edu | |
Principal Investigator: Thomas Lee, MD | |
United States, Florida | |
Bascom Palmer Eye Institute | Not yet recruiting |
Miami, Florida, United States, 33136 | |
Contact: Audina Berrocal, MD 305-326-6000 ext 5100 aberrocal@med.miami.edu | |
Principal Investigator: Audina Berrocal, MD | |
Sub-Investigator: Timothy Murray, MD | |
United States, Georgia | |
Emory Eye Center | Recruiting |
Atlanta, Georgia, United States, 30322 | |
Contact: Baker Hubbard, MD 404-778-5224 ghubba2@emory.edu | |
Principal Investigator: Baker Hubbard, MD | |
United States, Massachusetts | |
Children's Hospital / Dept. Ophthalmology | Not yet recruiting |
Boston, Massachusetts, United States, 02115 | |
Contact: Deborah Vanderveen, MD 617-355-8761 Deborah.Vanderveen@childrens.harvard.edu | |
Contact: Lois Smith, MD, PhD 617-355-8761 Lois.Smith@childrens.harvard.edu | |
Principal Investigator: Deborah Vanderveen, MD | |
Sub-Investigator: Lois Smith, MD, PhD | |
United States, Michigan | |
William Beaumont Hospital | Recruiting |
Royal Oak, Michigan, United States, 48073 | |
Contact: Kimberly Drenser, MD, PhD 248-288-2280 kimber@pol.net | |
Contact: Tammy Osentoski, RN 248-551-9866 TOsentoski@beaumont.edu | |
Principal Investigator: Kimberly Drenser, MD, PhD | |
United States, North Carolina | |
University of North Carolina/Ophthalmology | Not yet recruiting |
Chapel Hill, North Carolina, United States, 27599-7040 | |
Contact: Mary E Hartnett, MD 919-966-5296 hartnet@med.unc.edu | |
Principal Investigator: Mary E Hartnett, MD | |
United States, Pennsylvania | |
University of Pennsylvania/Scheie Eye Institute | Recruiting |
Philadelphia, Pennsylvania, United States, 19104 | |
Contact: Monte Mills, MD 210-590-5761 mills@email.chop.edu | |
Contact: Albert Maguire, MD | |
Principal Investigator: Monte Mills, MD | |
Sub-Investigator: Albert Maguire, MD | |
United States, Texas | |
Baylor College of Medicine | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: David Coats, MD 832-822-3234 dkcoats@texaschildrenshospital.org | |
Contact: Maria Castanes, MPH 832-822-3257 mscastan@texaschildrenshospital.org | |
Principal Investigator: David Coats, MD | |
Sub-Investigator: Eric Holz, MD | |
Canada, Alberta | |
Calgary Health | Not yet recruiting |
Calgary, Alberta, Canada, T2S-=2H4 | |
Contact: Anna Ells, MD 403-689-3952 anna.ells@calgaryhealthregion.ca | |
Principal Investigator: Anna Ells, MD |
Study Chair: | Michael T Trese, MD | Vision Research Foundation |
Responsible Party: | Vision Research Foundation ( Michael T. Trese, MD ) |
Study ID Numbers: | IND # 100,633, IND # 100,633 |
Study First Received: | June 19, 2008 |
Last Updated: | December 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00702819 |
Health Authority: | United States: Food and Drug Administration |
Pan-Vascular Endothelial Growth Factor Blockade Safety |
Eye Diseases Retinopathy of prematurity Infant, Newborn, Diseases Infant, Premature, Diseases |
Retinopathy of Prematurity Bevacizumab Endothelial Growth Factors Retinal Diseases |
Antineoplastic Agents Therapeutic Uses Growth Substances Physiological Effects of Drugs |
Growth Inhibitors Angiogenesis Modulating Agents Angiogenesis Inhibitors Pharmacologic Actions |