Condition category
Eye Diseases
Date applied
18/12/2006
Date assigned
15/05/2007
Last edited
15/05/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.fom.es/

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

Publication citations

Additional files

Editorial Notes