Contact information
Type
Scientific
Primary contact
Dr Amparo Navea
ORCID ID
Contact details
Fundación Oftalmológica del Mediterráneo
Bifurcación Pio Baroja-General Aviles s/n
Valencia
46015
Spain
navea_amp@gva.es
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
FOM-RETINA 1
Study information
Scientific title
Acronym
BTP-CSME
Study hypothesis
Clinically Significant Macular Edema (CSME) has no perfect treatment. Both grid photocoagulation and intraocular anti-angiogenic or corticosteroid substances have shown their utility. We want to determine the best combination to maintain/improve visual acuity and macular function.
Ethics approval
Approval pending from the Comité Ético de Investigación Clínica (Clinical Research Ethics Committee).
Study design
Prospective, randomised, single-centre, interventional trial.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Diabetic clinically significative diffuse macular edema
Intervention
Avastin group: intravitreal Bevacizumab 0.05 ml and then the same dose one and a half months later if edema is detected in Optical Coherence Tomography (OCT)
Triamcinolone group: intravitreal Triamcinolone 8 mg/0.1 ml and then the same dose three months later if edema is detected in OCT
Combination therapy group: Bevacizumab 0.05 ml followed by 8 mg/0.1 ml intravitreal triamcinolone seven days later, and the same dose three months later if needed (OCT detection)
Length of the treatment will be one year, then visual acuity will be evaluated, OCT performed and we will decide to interrupt or to continue if beneficial results can be expected.
Intervention type
Drug
Phase
Not Specified
Drug names
Bevacizumab, triamcinolone
Primary outcome measures
Visual acuity comparison
Secondary outcome measures
1. Macular visual field comparison
2. OCT variations of edema
Overall trial start date
01/01/2007
Overall trial end date
01/01/2008
Reason abandoned
Eligibility
Participant inclusion criteria
1. Diabetic CSME not treated previously
2. Best Corrected Visual Acuity (BCVA) less than 20/40
3. Patient able to complete follow-up
4. Controlled diabetes
Participant type
Patient
Age group
Not Specified
Gender
Both
Target number of participants
60
Participant exclusion criteria
1. Other associated ocular pathology
2. Ocular surgery three months before the inclusion
3. Participating in other interventional studies
Recruitment start date
01/01/2007
Recruitment end date
01/01/2008
Locations
Countries of recruitment
Spain
Trial participating centre
Fundación Oftalmológica del Mediterráneo
Valencia
46015
Spain
Sponsor information
Organisation
Opthalmological Foundation of the Mediterranean (Fundacion Oftalmologica del Mediterraneo) (Spain)
Sponsor details
Bifurcación Pio Baroja-General Aviles s/n
Valencia
46015
Spain
navea_amp@gva.es
Sponsor type
Research council
Website
Funders
Funder type
Research organisation
Funder name
Opthalmological Foundation of the Mediterranean (Fundacion Oftalmologica del Mediterraneo) (Spain)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary