Treatment of Clinically Significative diabetic Macular Edema: influence of Bevacizumab, Triamcinolone and the combination of both plus macular grid thermal laser Photocoagulation of subthreshold

ISRCTN ISRCTN10939948
DOI https://doi.org/10.1186/ISRCTN10939948
Secondary identifying numbers FOM-RETINA 1
Submission date
18/12/2006
Registration date
15/05/2007
Last edited
23/09/2021
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Eye Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Amparo Navea
Scientific

Fundación Oftalmológica del Mediterráneo
Bifurcación Pio Baroja-General Aviles s/n
Valencia
46015
Spain

Email navea_amp@gva.es

Study information

Study designProspective, randomised, single-centre, interventional trial.
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific titleTreatment of Clinically Significative diabetic Macular Edema: influence of Bevacizumab, Triamcinolone and the combination of both plus macular grid thermal laser Photocoagulation of subthreshold
Study acronymBTP-CSME
Study objectivesClinically 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(s)Approval pending from the Comité Ético de Investigación Clínica (Clinical Research Ethics Committee).
Health condition(s) or problem(s) studiedDiabetic clinically significative diffuse macular edema
InterventionAvastin 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Bevacizumab, triamcinolone
Primary outcome measureVisual acuity comparison
Secondary outcome measures1. Macular visual field comparison
2. OCT variations of edema
Overall study start date01/01/2007
Completion date01/01/2008

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexBoth
Target number of participants60
Key inclusion criteria1. 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
Key exclusion criteria1. Other associated ocular pathology
2. Ocular surgery three months before the inclusion
3. Participating in other interventional studies
Date of first enrolment01/01/2007
Date of final enrolment01/01/2008

Locations

Countries of recruitment

  • Spain

Study participating centre

Fundación Oftalmológica del Mediterráneo
Valencia
46015
Spain

Sponsor information

Opthalmological Foundation of the Mediterranean (Fundacion Oftalmologica del Mediterraneo) (Spain)
Research council

Bifurcación Pio Baroja-General Aviles s/n
Valencia
46015
Spain

Email navea_amp@gva.es
Website http://www.fom.es/

Funders

Funder type

Research organisation

Opthalmological Foundation of the Mediterranean (Fundacion Oftalmologica del Mediterraneo) (Spain)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Editorial Notes

23/09/2021: Proactive update review. No publications found. Search options exhausted.