Intravitreal versus subtenon triamcinolone acetonide for the treatment of diabetic cystoid macular oedema
| ISRCTN | ISRCTN67086909 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN67086909 |
| Protocol serial number | N/A |
| Sponsor | St Orsola Malpighi University Hospital Bologna (Italy) |
| Funder | St Orsola Malpighi University Hospital Bologna (Italy) |
- Submission date
- 05/02/2008
- Registration date
- 20/02/2008
- Last edited
- 15/04/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Mauro Cellini
Scientific
Scientific
Via Massarenti, 9
Bologna
40100
Italy
Study information
| Primary study design | Interventional |
|---|---|
| Study design | An interventional randomised double-blind study |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | Macular oedema is the main cause of loss of visual acuity in diabetic patients. It may occur at any stage of the retinal disorder and is the most common cause of sight reductions in these subjects. In the oedema, the haemato-retinal barrier is damaged by an alteration in the tight junction between the retinal capillary endothelial cells and the pigmented epithelial cells with the consequent leakage of water and electrolytes in the retinal tissue. The use of corticosteroids for the treatment of retinal oedema is linked to their capacity to inhibit the initial arachidonic acid cascade, to determine a down-regulation of the cytokines and to attenuate the tearing of the haemato-retinal barrier. Hypothesis: To assess the efficacy of the intravitreal (IVT) injection of triamcinolone acetonide (TA) as compared to posterior subtenon (SBT) capsule injection for the treatment of cystoid diabetic macular oedema. |
| Ethics approval(s) | Ethics approval received from the Institutional Ethics Committee of the S. Orsola-Malpighi Hospital on the 12th September 2006 (ref: OFC06-01). |
| Health condition(s) or problem(s) studied | Macular oedema |
| Intervention | For the IVT injection, the patient was placed supine and we performed a surface anaesthesia with topical 4% carbocaine followed by a preparation with 5% povidone iodine. A volume of 0.1 ml containing 4 mg preservative-free TA (Kenacort, Bristol-Myers Squibb, Sermoneta, Italy) was injected through the inferotemporal pars-plana (4.0 mm posterior to the limbus) using a 30-gauge needle. For the SBT injection, the patient was placed supine and after topical 0.4% oxybuprocaine surface anaesthesia we administered 0.5 ml of a 40 mg/ml peribulbar inferotemporal subtenon injection of preservative-free TA (Kenacort, Bristol-Myers Squibb, Sermoneta, Italy) with a 27-gauge needle. The follow-up was of 6 months for all treatment arms. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Triamcinolone acetonide |
| Primary outcome measure(s) |
Visual acuity was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) chart, measured every month until the end of follow-up. |
| Key secondary outcome measure(s) |
Macular thickness was measured by optical coherence tomography (OCT), measured every month until the end of follow-up. |
| Completion date | 18/10/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | All |
| Target sample size at registration | 28 |
| Key inclusion criteria | 1. Patients aged between 61 and 74 years (mean 68.3), either sex 2. With type II diabetes mellitus 3. On insulin treatment 4. Presenting diffuse macular oedema without retinal-vitreous traction |
| Key exclusion criteria | 1. History of focal/grid laser photocoagulation in the macula 2. Record of uveitis episodes 3. Previous ocular surgery, glaucoma and ocular hypertension |
| Date of first enrolment | 03/02/2004 |
| Date of final enrolment | 18/10/2004 |
Locations
Countries of recruitment
- Italy
Study participating centre
Via Massarenti, 9
Bologna
40100
Italy
40100
Italy
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 17/03/2008 | Yes | No |
