None listed
Conditions
Brief summary
We will conduct an open-label extension of a prospective, single centre, double-masked, placebo-controlled clinical trial of IVTA for diabetic macular oedema that persists or recurs after laser treatment. Sixty four of the originally enrolled 69 (93%) eyes are available to be followed. The primary outcome measures will be an increase of =5 letters at the 5-year study visit on a LogMAR chart compared with (a) the initial baseline level and (b) the level at the 2-year study visit. The incidence of moderate or severe adverse events over the 3 years of the open-label extension will also be a primary outcome. Secondary outcomes will include change in macular thickness by OCT, any change in visual acuity and number of laser treatments required. Standardised protocols have been developed for intravitreal injection, macular laser treatment, refraction and measurement of visual acuity. Treatment with triamcinolone will be offered to all patients, whether they previously received placebo or active treatment, on exit from the TDMO study. IVTA will be administered in the clinic under local anaesthesia. Treatments will be given at least 6 months apart according to prospectively identified criteria that take into account the previous and current visual acuity and macular thickness measured by OCT. The safety data will be monitored 6 monthly by an independent Safety Monitoring Committee.
Interventions
Results from our own randomised clinical trial, combined with anecdotal reports from other groups, suggests that intravitreal triamcinolone safely improves vision and reduces swelling for up to 2 years in most eyes with diabetic macular oedema which persists or recurs despite laser treatment. There are no data on longer term efficacy and safety. We will conduct an open-label extension of a prospective, single centre, double-masked, placebo-controlled clinical trial of IVTA for diabetic macular o
Results from our own randomised clinical trial, combined with anecdotal reports from other groups, suggests that intravitreal triamcinolone safely improves vision and reduces swelling for up to 2 years in most eyes with diabetic macular oedema which persists or recurs despite laser treatment. There are no data on longer term efficacy and safety. We will conduct an open-label extension of a prospective, single centre, double-masked, placebo-controlled clinical trial of IVTA for diabetic macular oedema that persists or recurs after laser treatment. Sixty four of the originally enrolled 69 (93%) eyes are available to be followed. Triamcinolone (0.1 ml Kenacort 40, 40mg/ml triamcinolone acetate, Bristol-Myers Squibb pharmaceuticals, Australia) will be injected into the vitreous in eyes which have persistent macular oedema (>250 micron) AND visual acuity of 6/9 or worse. Treatment will be withheld at the investigator’s discretion if 2 previous injections have failed to significantly (50 micron) reduce macular oedema. The duration of the patient follow-up is 3 years and the duration of the entire study is 4 years.
Sponsors
Professor Mark Gillies
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
0 to No maximum
Healthy volunteers
No
Inclusion criteria
All patients at the conclusion of the TDMO study. Currently we are still following 64 of the 69 (93%) eyes that were initially entered into the TDMO study that had reduced vision from diabetic macular oedema at baseline.
Exclusion criteria
Uncontrolled glaucoma; Loss of vision due to other causes (e.g. age related macular degeneration, myopic macular degeneration);known allergies to triamcinolone acetate; patient is already receiving systemic steroid treatment; intercurrent severe disease such as septicemia; any condition which would affect follow-up or photographic documentation (e.g. geographical, psycho-social, media opacities).
Outcome results
None listed