Condition category
Eye Diseases
Date applied
05/02/2008
Date assigned
20/02/2008
Last edited
15/04/2008
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 Mauro Cellini

ORCID ID

Contact details

Via Massarenti
9
Bologna
40100
Italy

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

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

Ethics approval received from the Institutional Ethics Committee of the S. Orsola-Malpighi Hospital on the 12th September 2006 (ref: OFC06-01).

Study design

An interventional randomised double-blind study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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 names

Triamcinolone acetonide

Primary outcome measures

Visual acuity was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) chart, measured every month until the end of follow-up.

Secondary outcome measures

Macular thickness was measured by optical coherence tomography (OCT), measured every month until the end of follow-up.

Overall trial start date

03/02/2004

Overall trial end date

18/10/2004

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

28

Participant 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

Recruitment start date

03/02/2004

Recruitment end date

18/10/2004

Locations

Countries of recruitment

Italy

Trial participating centre

Via Massarenti, 9
Bologna
40100
Italy

Sponsor information

Organisation

St Orsola Malpighi University Hospital Bologna (Italy)

Sponsor details

Ophthalmology Service
Department of Surgery and Transplant
via Massarenti
9
Bologna
40138
Italy

Sponsor type

University/education

Website

Funders

Funder type

Hospital/treatment centre

Funder name

St Orsola Malpighi University Hospital Bologna (Italy)

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

Results in http://www.ncbi.nlm.nih.gov/pubmed/18366650

Publication citations

  1. Results

    Cellini M, Pazzaglia A, Zamparini E, Leonetti P, Campos EC, Intravitreal vs. subtenon triamcinolone acetonide for the treatment of diabetic cystoid macular edema., BMC Ophthalmol, 2008, 8, 5, doi: 10.1186/1471-2415-8-5.

Additional files

Editorial Notes