Retinopathy of PrematurityPhase 4NCT00500396
Vascular Endothelial Growth Factor in Stage V ROP
A Phase 4 study testing Open-Sky Vitrectomy in people with Retinopathy of Prematurity, run by Asociación para Evitar la Ceguera en México at 1 site in Mexico.
Trial summary
Vascular Endothelial Growth Factor (VEGF) is a dimeric glycoprotein, naturally expressed in epithelial and tumor cells (1). Normal Retinal vascularization has two phases: In the first fase, cells of mesenquimatous origin form the first superficial plexus (14-21 weeks of gestation). Read more about this study
- Who is it for?
- Ages 2 months to 10 years
- Conditions the study is for
- Retinopathy of Prematurity
- What is being tested?
- Open-Sky Vitrectomy
- Type of treatment
- Surgery or procedure
- How many people
- 15 participants
- Where
- 1 siteMexico
- Study dates
- Mar 2007to Jun 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 months to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Premature newborns with less than 32 weeks of gestation.
- Low birth weight (less than 1500gr) Stage V ROP.
- The parents has signed the informed consent.
Who cannot join
- Previous treatment of ROP.
- Surgery or another ocular pathology of any type.
- Systemic diseases, including diabetes mellitus, congestive heart failure acute renal insufficiency, Chronic renal insufficiency, high blood pressure.
- Lack of Informed consent.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Asociación para Evitar la Ceguera en Mexico
Mexico City, Mexico City, 04030
About this study
Official title: Vascular Endothelial Growth Factor Levels in Aqueous, Vitreous and Subretinal Fluid in Patients With Retinopathy of Prematurity Stage V.
Vascular Endothelial Growth Factor (VEGF) is a dimeric glycoprotein, naturally expressed in epithelial and tumor cells (1). Normal Retinal vascularization has two phases: In the first fase, cells of mesenquimatous origin form the first superficial plexus (14-21 weeks of gestation). In the second phase, denominated "angiogenesis phase", the superficial and deep capillary plexus are formed (15,20). The Retinopathy of Prematurity (ROP) was described for the first time in 1942 (4), at the present moment it is a public health problem in the developing countries. The International Classification of ROP classifies it in 5 stages, dividing it in 3 anatomical zones. It is a public health problem that continuous without having an effective prophylaxis. The early diagnosis and treatment in thresholds stages have changed the prognosis of this disease (11,12).
Read the detailed description
Vascular Endothelial Growth Factor (VEGF) is a dimeric glycoprotein, naturally expressed in epithelial and tumor cells (1). In conditions of hypoxia it is secreted by the pericytes, the Retina Pigmented epithelium (RPE)and glial cells, including a the Müller cells (1,2,4,5) favoring the formation of new abnormal vessels (1). Its activity is mediated by two high affinity receptors: the receptor VEGF 1 (FLT-1) and VEGF 2 (FLT-2) (1,9). The FLT-1 promotes cellular proliferation whereas FLT-2 the migration and cell- extracellular matrix interaction (9). The VEGF is essential as much for the normal retinal vascularization as for pathological (5,14).
Normal Retinal vascularization has two phases: In the first fase, cells of mesenquimatous origin form the first superficial plexus (14-21 weeks of gestation). In the second phase, denominated "angiogenesis phase", the superficial and deep capillary plexus are formed (15,20). The second phase is highly dependent of VEGF induced by hypoxia (15,20). In the normal retina the growth occurs from the optical nerve to the periphery (17).
The scientific progress in the neonatal intensive care units in the last years has allowed the survival of a larger number of premature newborns(15).
The Retinopathy of Prematurity (ROP)(ROP) was described for the first time in 1942 (4), at the present moment it is a public health problem in the developing countries. Of each 100.000 blind child in Latin America, 24.000 are due to ROP (240/1000 blind child) (17). It is the main cause of blindness in premature new born (1,4,5). It is of multifactorial etiology (17) but it has been related to a short gestational age (smaller to 32 weeks of gestation) (4), to low birth weight (less of 1500gr) or very low birth weight (less 1250gr)(1,4,5,17,18,20), to the administration of high oxygen concentration immediately after birth (1,3,18), low levels of the Insulin-like growth factor(IGF-I) and excessive production of VEGF (3,17).
All this, combined with large periods of hyperoxia-hypoxia, Produces that the normal vascularization of the retina stops. This also produces vascular-occlusive changes, arteriovenous anastomoses in the edge of the vascularized with the none-vascularized retina (18), begins the formation of abnormal vessels towards the vitreous, finally lead to retina detachment in the most severe cases (2,3,4,5).
The International Classification of ROP classifies it in 5 stages, dividing it in 3 anatomical zones. A threshold stage is considered when we have the presence of stage 3, in zone 1 or 2 in 5 continuous hour uses or 8 discontinuous with plus disease (15,16,17). The pre-threshold stage is divided in two types: type 1 is any stage of the disease in zone 1 with plus disease, stage 3, without plus disease in zone 1 or stage 2 or 3 with plus in zone 2. Type 2 is stage 1 or 2 without plus disease in zone 1 or stage 3 without plus disease in zone 2 (17,19). The threshold stage happens approximately in 5% of the patients with very low weight to the birth, of which the 10-15% develop blindness (6,8)
It is a public health problem that continuous without having an effective prophylaxis (5), nevertheless the use of constant oxygen concentrations, avoiding the periods of hyperoxia-hypoxia, has demonstrated to produce a decrease of the presentation of advanced stages of the disease and the necessity of ophthalmological surgery (5). The early diagnosis and treatment in thresholds stages have changed the prognosis of this disease (11,12). The use of the laser as treatment in the threshold and prethreshold stages is successful in the 91-95% of the cases(10), the ablative effect on the neurons, probably diminishes the VEGF production (15). The use of the vitrectomy in the early cases of retinal detachment also has good results (13).
For the determination and the quantification of VEGF several laboratory techniques have been used, as they are the Westernblot (1), the flow cytometry (7), CBA (7). Nevertheless, the Enzyme-linked immunoabsorbent assay (ELISA) remains the gold standard for the measurement of interleukins, growth factors and other cytokines in corporal fluids, including the vitreous, aqueous and subretinal fluid (1,5,7).
It has been demonstrated in humans that there are high vitreous concentrations of VEGF in eyes with active neovascularization (6,14). In the same way, the animal models of ROP report high levels of VEGF (2,21). The levels of this growth factor are altered in both stages, with a more marked increase during the first stage (2). Some clinical studies in patients with ROP in stage 4 and 5 have reported an increase of up to 90 times greater of the concentration of VEGF in the subretinal liquid in comparison with the found in patients with retinal detachment of any other cause (1). Finally, when it has been possible to examine retinas immediately after the treatment (due to death of the patient) have been found a low expression of mRNA of VEGF in the treated cells (6).
- Conditions
- Retinopathy of Prematurity
- Being tested
- Open-Sky Vitrectomy
- Keywords
- Retinopathy of Prematurity., ROP., Vascular Endothelial Growth Factor., VEGF., Vitreous., Subretinal Fluid., ELISA.
- Medical subject headings
- Retinopathy of Prematurity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open-Sky VitrectomyProcedure or surgery
Also called Vitrectomy
Open-Sky vitrectomy with removal of the Tunica vasculosa lentis and retinal reattachment
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the degree of VEGF in aqueous, vitreous and SRF in patients with ROP in stage V. Verifying that it is greater to that found in healthy newborn patients with different ocular pathology
Measured: 4 months
Secondary outcomes (2)
To establish a relation between the low and very low birth weight with the VEGF levels.
Measured: 4 months
To prove that the VEGF level found in ROP patients is greater than in other pathologies that normally produce neovessels (like in DM).
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2007 (estimated)
- Study startMar 2007
- Study completionJun 2007
Why it stopped: Undefined
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Retinopathy of PrematurityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asociación para Evitar la Ceguera en México
- Sponsor type
- University, hospital or other
- Investigators
- Hugo Quiroz-Mercado, MD, Principal investigator, Asociación para Evitar la Ceguera en MéxicoRaul Velez-Montoya, MD, Principal investigator, Asociación para Evitar la Ceguera en Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00500396
- Sponsor's protocol ID
- VEGFROP
- Status last verified
- May 2024
- First submitted
- 10 Jul 2007
- Last updated
- 30 May 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
Lashkari K, Hirose T, Yazdany J, McMeel JW, Kazlauskas A, Rahimi N. Vascular endothelial growth factor and hepatocyte growth factor levels are differentially elevated in patients with advanced retinopathy of prematurity. Am J Pathol. 2000 Apr;156(4):1337-44. doi: 10.1016/S0002-9440(10)65004-3.
PubMed 10751359Pierce EA, Foley ED, Smith LE. Regulation of vascular endothelial growth factor by oxygen in a model of retinopathy of prematurity. Arch Ophthalmol. 1996 Oct;114(10):1219-28. doi: 10.1001/archopht.1996.01100140419009.
PubMed 8859081Gaynon MW. Rethinking STOP-ROP: is it worthwhile trying to modulate excessive VEGF levels in prethreshold ROP eyes by systemic intervention? A review of the role of oxygen, light adaptation state, and anemia in prethreshold ROP. Retina. 2006 Sep;26(7 Suppl):S18-23. doi: 10.1097/01.iae.0000244292.86627.1e.
PubMed 16946672Hellstrom A, Perruzzi C, Ju M, Engstrom E, Hard AL, Liu JL, Albertsson-Wikland K, Carlsson B, Niklasson A, Sjodell L, LeRoith D, Senger DR, Smith LE. Low IGF-I suppresses VEGF-survival signaling in retinal endothelial cells: direct correlation with clinical retinopathy of prematurity. Proc Natl Acad Sci U S A. 2001 May 8;98(10):5804-8. doi: 10.1073/pnas.101113998. Epub 2001 May 1.
PubMed 11331770Modanlou HD, Gharraee Z, Hasan J, Waltzman J, Nageotte S, Beharry KD. Ontogeny of VEGF, IGF-I, and GH in neonatal rat serum, vitreous fluid, and retina from birth to weaning. Invest Ophthalmol Vis Sci. 2006 Feb;47(2):738-44. doi: 10.1167/iovs.05-1046.
PubMed 16431975Cooke RW, Drury JA, Mountford R, Clark D. Genetic polymorphisms and retinopathy of prematurity. Invest Ophthalmol Vis Sci. 2004 Jun;45(6):1712-5. doi: 10.1167/iovs.03-1303.
PubMed 15161830Maier R, Weger M, Haller-Schober EM, El-Shabrawi Y, Theisl A, Barth A, Aigner R, Haas A. Application of multiplex cytometric bead array technology for the measurement of angiogenic factors in the vitreous. Mol Vis. 2006 Oct 2;12:1143-7.
PubMed 17093399Phelps DL; ETROP Cooperative Group. The Early Treatment for Retinopathy of Prematurity study: better outcomes, changing strategy. Pediatrics. 2004 Aug;114(2):490-1. doi: 10.1542/peds.114.2.490. No abstract available.
PubMed 15286235Yoo MH, Hyun HJ, Koh JY, Yoon YH. Riluzole inhibits VEGF-induced endothelial cell proliferation in vitro and hyperoxia-induced abnormal vessel formation in vivo. Invest Ophthalmol Vis Sci. 2005 Dec;46(12):4780-7. doi: 10.1167/iovs.05-0376.
PubMed 16303979Hurley BR, McNamara JA, Fineman MS, Ho AC, Tasman W, Kaiser RS, Vander JF, Regillo CD, Brown GC. Laser treatment for retinopathy of prematurity: evolution in treatment technique over 15 years. Retina. 2006 Sep;26(7 Suppl):S16-7. doi: 10.1097/01.iae.0000244293.94251.20.
PubMed 16946671Multicenter trial of cryotherapy for retinopathy of prematurity. Preliminary results. Cryotherapy for Retinopathy of Prematurity Cooperative Group. Arch Ophthalmol. 1988 Apr;106(4):471-9. doi: 10.1001/archopht.1988.01060130517027.
PubMed 2895630Cryotherapy for Retinopathy of Prematurity Cooperative Group. Multicenter Trial of Cryotherapy for Retinopathy of Prematurity: ophthalmological outcomes at 10 years. Arch Ophthalmol. 2001 Aug;119(8):1110-8. doi: 10.1001/archopht.119.8.1110.
PubMed 11483076Kychenthal A, Dorta P, Katz X. Zone I retinopathy of prematurity: clinical characteristics and treatment outcomes. Retina. 2006 Sep;26(7 Suppl):S11-5. doi: 10.1097/01.iae.0000244285.79004.e6.
PubMed 16946670Itakura H, Kishi S, Kotajima N, Murakami M. Persistent secretion of vascular endothelial growth factor into the vitreous cavity in proliferative diabetic retinopathy after vitrectomy. Ophthalmology. 2004 Oct;111(10):1880-4. doi: 10.1016/j.ophtha.2004.03.035.
PubMed 15465550Flynn JT, Chan-Ling T. Retinopathy of prematurity: two distinct mechanisms that underlie zone 1 and zone 2 disease. Am J Ophthalmol. 2006 Jul;142(1):46-59. doi: 10.1016/j.ajo.2006.02.018.
PubMed 16815250
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vascular Endothelial Growth Factor Levels in Aqueous, Vitreous and Subretinal Fluid in Patients With Retinopathy of Prematurity Stage V.
- ClinicalTrials.gov ID
- NCT00500396
- Acronym / sponsor ID
- VEGFROP
- Conditions
- Retinopathy of Prematurity
- Keywords
- Retinopathy of Prematurity., ROP., Vascular Endothelial Growth Factor., VEGF., Vitreous., Subretinal Fluid., ELISA.
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Undefined
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Asociación para Evitar la Ceguera en MéxicoUniversity, hospital or other
- Study start
- Mar 2007
- Study completion
- Jun 2007 (actual)
- First posted
- 12 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Vascular Endothelial Growth Factor (VEGF) is a dimeric glycoprotein, naturally expressed in epithelial and tumor cells (1). Normal Retinal vascularization has two phases: In the first fase, cells of mesenquimatous origin form the first superficial plexus (14-21 weeks of gestation). In the second phase, denominated "angiogenesis phase", the superficial and deep capillary plexus are formed (15,20). The Retinopathy of Prematurity (ROP) was described for the first time in 1942 (4), at the present moment it is a public health problem in the developing countries. The International Classification of ROP classifies it in 5 stages, dividing it in 3 anatomical zones. It is a public health problem that continuous without having an effective prophylaxis. The early diagnosis and treatment in thresholds stages have changed the prognosis of this disease (11,12).
Detailed description
Vascular Endothelial Growth Factor (VEGF) is a dimeric glycoprotein, naturally expressed in epithelial and tumor cells (1). In conditions of hypoxia it is secreted by the pericytes, the Retina Pigmented epithelium (RPE)and glial cells, including a the Müller cells (1,2,4,5) favoring the formation of new abnormal vessels (1). Its activity is mediated by two high affinity receptors: the receptor VEGF 1 (FLT-1) and VEGF 2 (FLT-2) (1,9). The FLT-1 promotes cellular proliferation whereas FLT-2 the migration and cell- extracellular matrix interaction (9). The VEGF is essential as much for the normal retinal vascularization as for pathological (5,14).
Normal Retinal vascularization has two phases: In the first fase, cells of mesenquimatous origin form the first superficial plexus (14-21 weeks of gestation). In the second phase, denominated "angiogenesis phase", the superficial and deep capillary plexus are formed (15,20). The second phase is highly dependent of VEGF induced by hypoxia (15,20). In the normal retina the growth occurs from the optical nerve to the periphery (17).
The scientific progress in the neonatal intensive care units in the last years has allowed the survival of a larger number of premature newborns(15).
The Retinopathy of Prematurity (ROP)(ROP) was described for the first time in 1942 (4), at the present moment it is a public health problem in the developing countries. Of each 100.000 blind child in Latin America, 24.000 are due to ROP (240/1000 blind child) (17). It is the main cause of blindness in premature new born (1,4,5). It is of multifactorial etiology (17) but it has been related to a short gestational age (smaller to 32 weeks of gestation) (4), to low birth weight (less of 1500gr) or very low birth weight (less 1250gr)(1,4,5,17,18,20), to the administration of high oxygen concentration immediately after birth (1,3,18), low levels of the Insulin-like growth factor(IGF-I) and excessive production of VEGF (3,17).
All this, combined with large periods of hyperoxia-hypoxia, Produces that the normal vascularization of the retina stops. This also produces vascular-occlusive changes, arteriovenous anastomoses in the edge of the vascularized with the none-vascularized retina (18), begins the formation of abnormal vessels towards the vitreous, finally lead to retina detachment in the most severe cases (2,3,4,5).
The International Classification of ROP classifies it in 5 stages, dividing it in 3 anatomical zones. A threshold stage is considered when we have the presence of stage 3, in zone 1 or 2 in 5 continuous hour uses or 8 discontinuous with plus disease (15,16,17). The pre-threshold stage is divided in two types: type 1 is any stage of the disease in zone 1 with plus disease, stage 3, without plus disease in zone 1 or stage 2 or 3 with plus in zone 2. Type 2 is stage 1 or 2 without plus disease in zone 1 or stage 3 without plus disease in zone 2 (17,19). The threshold stage happens approximately in 5% of the patients with very low weight to the birth, of which the 10-15% develop blindness (6,8)
It is a public health problem that continuous without having an effective prophylaxis (5), nevertheless the use of constant oxygen concentrations, avoiding the periods of hyperoxia-hypoxia, has demonstrated to produce a decrease of the presentation of advanced stages of the disease and the necessity of ophthalmological surgery (5). The early diagnosis and treatment in thresholds stages have changed the prognosis of this disease (11,12). The use of the laser as treatment in the threshold and prethreshold stages is successful in the 91-95% of the cases(10), the ablative effect on the neurons, probably diminishes the VEGF production (15). The use of the vitrectomy in the early cases of retinal detachment also has good results (13).
For the determination and the quantification of VEGF several laboratory techniques have been used, as they are the Westernblot (1), the flow cytometry (7), CBA (7). Nevertheless, the Enzyme-linked immunoabsorbent assay (ELISA) remains the gold standard for the measurement of interleukins, growth factors and other cytokines in corporal fluids, including the vitreous, aqueous and subretinal fluid (1,5,7).
It has been demonstrated in humans that there are high vitreous concentrations of VEGF in eyes with active neovascularization (6,14). In the same way, the animal models of ROP report high levels of VEGF (2,21). The levels of this growth factor are altered in both stages, with a more marked increase during the first stage (2). Some clinical studies in patients with ROP in stage 4 and 5 have reported an increase of up to 90 times greater of the concentration of VEGF in the subretinal liquid in comparison with the found in patients with retinal detachment of any other cause (1). Finally, when it has been possible to examine retinas immediately after the treatment (due to death of the patient) have been found a low expression of mRNA of VEGF in the treated cells (6).
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 2 months to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Premature newborns with less than 32 weeks of gestation.
- Low birth weight (less than 1500gr) Stage V ROP.
- The parents has signed the informed consent.
Key exclusion criteria (4 listed)
- Previous treatment of ROP.
- Surgery or another ocular pathology of any type.
- Systemic diseases, including diabetes mellitus, congestive heart failure acute renal insufficiency, Chronic renal insufficiency, high blood pressure.
- Lack of Informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Open-Sky VitrectomyAlso: VitrectomyOpen-Sky vitrectomy with removal of the Tunica vasculosa lentis and retinal reattachment | Procedure or surgery | – |
Primary outcome
To determine the degree of VEGF in aqueous, vitreous and SRF in patients with ROP in stage V. Verifying that it is greater to that found in healthy newborn patients with different ocular pathology
Time frame: 4 months
2 secondary outcomes
To establish a relation between the low and very low birth weight with the VEGF levels.
Time frame: 4 months
To prove that the VEGF level found in ROP patients is greater than in other pathologies that normally produce neovessels (like in DM).
Time frame: 4 months
Results and safety
The study was stopped early (reason given: Undefined). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2024.
- Background: PubMed 10751359Lashkari K, Hirose T, Yazdany J, McMeel JW, Kazlauskas A, Rahimi N. Vascular endothelial growth factor and hepatocyte growth factor levels are differentially elevated in patients with advanced retinopathy of prematurity. Am J Pathol. 2000 Apr;156(4):1337-44. doi: 10.1016/S0002-9440(10)65004-3.
- Background: PubMed 8859081Pierce EA, Foley ED, Smith LE. Regulation of vascular endothelial growth factor by oxygen in a model of retinopathy of prematurity. Arch Ophthalmol. 1996 Oct;114(10):1219-28. doi: 10.1001/archopht.1996.01100140419009.
- Background: PubMed 16946672Gaynon MW. Rethinking STOP-ROP: is it worthwhile trying to modulate excessive VEGF levels in prethreshold ROP eyes by systemic intervention? A review of the role of oxygen, light adaptation state, and anemia in prethreshold ROP. Retina. 2006 Sep;26(7 Suppl):S18-23. doi: 10.1097/01.iae.0000244292.86627.1e.
- Background: PubMed 11331770Hellstrom A, Perruzzi C, Ju M, Engstrom E, Hard AL, Liu JL, Albertsson-Wikland K, Carlsson B, Niklasson A, Sjodell L, LeRoith D, Senger DR, Smith LE. Low IGF-I suppresses VEGF-survival signaling in retinal endothelial cells: direct correlation with clinical retinopathy of prematurity. Proc Natl Acad Sci U S A. 2001 May 8;98(10):5804-8. doi: 10.1073/pnas.101113998. Epub 2001 May 1.
- Background: PubMed 16431975Modanlou HD, Gharraee Z, Hasan J, Waltzman J, Nageotte S, Beharry KD. Ontogeny of VEGF, IGF-I, and GH in neonatal rat serum, vitreous fluid, and retina from birth to weaning. Invest Ophthalmol Vis Sci. 2006 Feb;47(2):738-44. doi: 10.1167/iovs.05-1046.
- Background: PubMed 15161830Cooke RW, Drury JA, Mountford R, Clark D. Genetic polymorphisms and retinopathy of prematurity. Invest Ophthalmol Vis Sci. 2004 Jun;45(6):1712-5. doi: 10.1167/iovs.03-1303.
- Background: PubMed 17093399Maier R, Weger M, Haller-Schober EM, El-Shabrawi Y, Theisl A, Barth A, Aigner R, Haas A. Application of multiplex cytometric bead array technology for the measurement of angiogenic factors in the vitreous. Mol Vis. 2006 Oct 2;12:1143-7.
- Background: PubMed 15286235Phelps DL; ETROP Cooperative Group. The Early Treatment for Retinopathy of Prematurity study: better outcomes, changing strategy. Pediatrics. 2004 Aug;114(2):490-1. doi: 10.1542/peds.114.2.490. No abstract available.
- Background: PubMed 16303979Yoo MH, Hyun HJ, Koh JY, Yoon YH. Riluzole inhibits VEGF-induced endothelial cell proliferation in vitro and hyperoxia-induced abnormal vessel formation in vivo. Invest Ophthalmol Vis Sci. 2005 Dec;46(12):4780-7. doi: 10.1167/iovs.05-0376.
- Background: PubMed 16946671Hurley BR, McNamara JA, Fineman MS, Ho AC, Tasman W, Kaiser RS, Vander JF, Regillo CD, Brown GC. Laser treatment for retinopathy of prematurity: evolution in treatment technique over 15 years. Retina. 2006 Sep;26(7 Suppl):S16-7. doi: 10.1097/01.iae.0000244293.94251.20.
- Background: PubMed 2895630Multicenter trial of cryotherapy for retinopathy of prematurity. Preliminary results. Cryotherapy for Retinopathy of Prematurity Cooperative Group. Arch Ophthalmol. 1988 Apr;106(4):471-9. doi: 10.1001/archopht.1988.01060130517027.
- Background: PubMed 11483076Cryotherapy for Retinopathy of Prematurity Cooperative Group. Multicenter Trial of Cryotherapy for Retinopathy of Prematurity: ophthalmological outcomes at 10 years. Arch Ophthalmol. 2001 Aug;119(8):1110-8. doi: 10.1001/archopht.119.8.1110.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hugo Quiroz-Mercado, MD principal investigator
Asociación para Evitar la Ceguera en México
Raul Velez-Montoya, MD principal investigator
Asociación para Evitar la Ceguera en Mexico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Open-Sky Vitrectomy in people with Retinopathy of Prematurity, run by Asociación para Evitar la Ceguera en México at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Undefined). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the degree of VEGF in aqueous, vitreous and SRF in patients with ROP in stage V. Verifying that it is greater to that found in healthy newborn patients with different ocular pathology (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00500396, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2024.