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
Scientific
Fundación Oftalmológica del Mediterráneo
Bifurcación Pio Baroja-General Aviles s/n
Valencia
46015
Spain
| navea_amp@gva.es |
Study information
| Study design | Prospective, randomised, single-centre, interventional trial. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | Treatment of Clinically Significative diabetic Macular Edema: influence of Bevacizumab, Triamcinolone and the combination of both plus macular grid thermal laser Photocoagulation of subthreshold |
| Study acronym | BTP-CSME |
| Study objectives | 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(s) | Approval pending from the Comité Ético de Investigación Clínica (Clinical Research Ethics Committee). |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Bevacizumab, triamcinolone |
| Primary outcome measure | Visual acuity comparison |
| Secondary outcome measures | 1. Macular visual field comparison 2. OCT variations of edema |
| Overall study start date | 01/01/2007 |
| Completion date | 01/01/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Both |
| Target number of participants | 60 |
| Key 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 |
| Key exclusion criteria | 1. Other associated ocular pathology 2. Ocular surgery three months before the inclusion 3. Participating in other interventional studies |
| Date of first enrolment | 01/01/2007 |
| Date of final enrolment | 01/01/2008 |
Locations
Countries of recruitment
- Spain
Study participating centre
Fundación Oftalmológica del Mediterráneo
Valencia
46015
Spain
46015
Spain
Sponsor information
Opthalmological Foundation of the Mediterranean (Fundacion Oftalmologica del Mediterraneo) (Spain)
Research council
Research council
Bifurcación Pio Baroja-General Aviles s/n
Valencia
46015
Spain
| 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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
23/09/2021: Proactive update review. No publications found. Search options exhausted.
