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NCT00346814 Clinical Trial

Antiangiogenic Therapy With Bevacizumab in Retinopathy of Prematurity. Structural Outcome

Retinopathy of Prematurity Clinical Trial

Official title:
Antiangiogenic Therapy With Bevacizumab in Retinopathy of Prematurity. Structural Outcome

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00346814
Other study ID # APEC-001
Secondary ID
Status Recruiting
Phase Phase 2/Phase 3
First received June 29, 2006
Last updated June 28, 2009
Start date July 2006
Est. completion date November 2006

Study information
Verified date June 2006
Source Asociación para Evitar la Ceguera en México
Contact Hugo Quiroz-Mercado, MD
Phone 525510841400
Email retinamex@yahoo.com
Is FDA regulated No
Health authority Mexico: Ministry of Health
Study type Interventional

Clinical Trial Summary

Purpose:Retinopathy of prematurity (ROP) continues tobe a major cause of blindness in children. Although ablation of the retina with laser or cryotherapy reduces the incidence of blindness by suppressing the neovascular phase of ROP the visual outcomes after treatment are often poor. Vascular endothelial growth factor(VEGF) has an important role in the pathogenesis of ROP and inhibition of VEGF expression in the neovascular phase might prevent destructive neovascularization in ROP. The aim of this study is to determine the safety and efficacy of intravitreal bevacizumab in the treatment of retinopathy of prematurity

Recruitment information / eligibility
Status Recruiting
Enrollment 0
Est. completion date November 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 1 Month to 12 Months
Eligibility Inclusion Criteria:

- Retinopathy of prematurity stages III, IV and V in which we can not treat with laser o cryotherAPY

Exclusion Criteria:

- PATIENTS THAT COULD BE TREATED WITH CRYOTHERAPY OR LASER

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• intravitreal injection

Locations
Country Name City State
Mexico Asociación para Evitar la Ceguera en México Hospital "Luis Sanchez Bulnes" Mexico City Mexico DF

Sponsors (1)
Lead Sponsor Collaborator
Asociación para Evitar la Ceguera en México

Country where clinical trial is conducted

Mexico, 

Outcome
Type Measure Description Time frame Safety issue
Primary Clinical appearance
See also
  Status Clinical Trial Phase
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Completed NCT04838665 - Changes in Vital Signs and Pupil Diameter Related to Pharmacologic Mydriasis in Premature Infants: A Randomized Double Blind Clinical Study Phase 4
Completed NCT04408807 - Stress Induced by Screening for Retinopathy of Prematurity - Should Speculum and Indentation Rather be Avoided N/A
Recruiting NCT03083431 - Oral Propranolol for Prevention of Threshold Retinopathy of Prematurity Phase 2
Enrolling by invitation NCT04985448 - Real World Study of the Effectiveness and Safety of Conbercept Ophthalmic Injection in the Treatment of Retinopathy of Prematurity - Multicenter, Retrospective and Observational Study Based on Real World Data
Recruiting NCT02090322 - Bevacizumab 0.500MG Intravitreal There Isn't Lower Than 0.625MG in the Treatment of ROP Type 1 N/A
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Terminated NCT01335113 - A Scan Ultrasonography in the Evaluation of Retinopathy of Prematurity
Active, not recruiting NCT00027222 - The Early Treatment for Retinopathy of Prematurity Study (ETROP) Phase 2/Phase 3
Recruiting NCT06109285 - Validation of i-ROP DL to Detect More Than Mild ROP N/A
Completed NCT02014454 - Safety and Efficacy of Propranolol Eye Drops in Treating Retinopathy of Premature Phase 2
Completed NCT01861470 - REDEXAM - Reducing Painful Eye Examinations in Preterm Infants N/A
Terminated NCT00634972 - Efficient Study of ACULAR in Inhibiting Proliferative Retinopathy in Prematurity Phase 4
Completed NCT05701124 - Intravitreal Ranibizumab Injection for Aggressive Versus Type 1 Prethreshold Retinopathy of Prematurity Phase 3
Completed NCT04092127 - Pain of Premature Babies and RetCam (DOLICAM)
Completed NCT04621136 - PhaseI/II Investigator-Initiated Trial to Investigate Safety and Efficacy of Ripasudil in Patients With Retinopathy of Prematurity Phase 1/Phase 2