Safety and effectiveness of intravitreal bevacizumab and ranibizumab injections for treatment of retinal disease patients: an observational study

• Register: TCTR
• Last refreshed on: 29 April 2024
• Main ID: TCTR20141002001
• Date of registration: 02/10/2014
• Prospective Registration: No
• Primary sponsor: Health Intervention and Technology Assessment Program (HITAP)
• Public title: Safety and effectiveness of intravitreal bevacizumab and ranibizumab injections for treatment of retinal disease patients: an observational study
• Scientific title: Safety and effectiveness of intravitreal bevacizumab and ranibizumab injections for treatment of retinal disease patients: an observational study
• Date of first enrolment: 28/01/2013
• Target sample size: 6399
• Recruitment status: Completed
• URL: https://www.thaiclinicaltrials.org/show/TCTR20141002001
• Study type: Observational
• Study design: Non-randomized
• Phase: N/A

Countries of recruitment

Thailand

Contacts

• Name: Sermsiri Sangroongruangsri
• Affiliation: HITAP

• Name: Sermsiri Sangroongruangsri
• Affiliation: HITAP

Key inclusion & exclusion criteria

Inclusion criteria: � Sign informed consent which was approved by the institutional review board (IRB)/ independent ethics committees (IECs) of each hospital.
� age ≥ 18 years of either gender.
� be patients with retinal diseases who are treated or will be treated (previously untreated) with IVB or IVR before participating in this study.
� no contraindication to IVB or IVR such as allergy to the active ingredient or their excipients.
� no condition of infection around or at the eyes before receiving IVR.
� can participate in the study for at least 6 months after the enrollment.
Exclusion criteria: � have contraindication of bevacizumab or ranibizumab and their excipients
� switch between the investigational drugs within 6 months before the enrolment and during the 6-month of the study period
Data collection of any subjects will be terminated when
� switch between the investigational drugs during the follow up period
� subjects want to withdraw from the study

Age minimum: 18 Years
Age maximum: 0 N/A (No limit)
Gender: Both

Health Condition(s) or Problem(s) studied

neovascular age-related macular degeneration (neovascular AMD)
diabetic macular edema (DME)
retinal vein occlusion(RVO)

retinal diseases or conditions that can be treated with bevacizumab or ranibizumab such as neovascular age-related macular degeneration (neovascular AMD), diabetic macular edema (DME), and macular ede
neovascular age-related macular degeneration (neovascular AMD)
diabetic macular edema (DME)
retinal vein occlusion(RVO)

Intervention(s)

prior anti-VEGF treated and anti-VEGF-naive patients who are going to receive intravitreal bevacizumab injection (IVB) during the study period ,prior anti-VEGF treated and anti-VEGF-naive patients who are going to receive intravitreal ranibizumab injection (IVR) during the study period

patients treated with intravitreal bevacizumab,patients treated with intravitreal ranibizumab

Treatment,Treatment

Primary Outcome(s)

nonfatal stroke withing one month after the intravitreal injection within 6 months case report form (data from medical records, patient-interview, and national databases),endophthalmitis withing one month after the intravitreal injection within 6 months case report form (data from medical records, patient-interview, and national databases)

Secondary Outcome(s)

change of best corrected visual acuity (BCVA) and CMT withing one month after the intravitreal injection within 6 months case report form (data from medical records, patient-interview, and national databases),arteriothrombotic and venous thrombotic events; upper GI bleeding; congestive heart failure withing one month after the intravitreal injection within 6 months case report form (data from medical records, patient-interview, and national databases)

Secondary ID(s)

N/A

Source(s) of Monetary Support

Health System Research Institute (HSRI)

Ethics review

Status: Submitted, approved
Approval date:
Contact:

Ethic committee: Institute for the Development of Human Research Protections (IHRP)

02-5913876, 02-5913541 Ext.

Results

• Date Completed: 19/06/2015