To show in a prospective randomised study if intravitreal injection of Triamcinolonacetonide combined with Macula Grid Laser gives a better increase in visual acuity and/or decrease in macular edema than Macula Grid Laser combined with sub-Tenon…
ID
Source
Brief title
Condition
- Retina, choroid and vitreous haemorrhages and vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Change in mean ETDRS visual acuity 6 months after Macula Grid Laser and change
in macular thickness measured by OCT compared to the situation before
treatment.
Secondary outcome
Change in visual acuity. Subjective change in visual acuity. Laserenergy needed
for minimal visible effect. Incidence of side effects as rise in intraocular
pressure, cataract formation, endophthalmitis, retinal detachment. Amount of
leakage on fluorescein angiography.
Background summary
Diabetic Macular Edema is the most frequent cause of visual impairment in
patients with Diabetic Retinopathy.
Our study will compare the effect of two therapies for Diffuse Diabetic Macular
Edema.
Diffuse Diabetic Macular Edema can be treated in different ways. Macula Grid
Laser photocoagulation (MGL) is a well-known treatment to stabilise the visual
acuity.
Intravitreal Triamcinolonacetonide is another treatment for Diffuse Diabetic
Macular Edema and causes a strong decrease in macular edema and increase in
visual acuity, but has a limitid effect from 2 to 6 months.
At the moment Diffuse Diabetic Macular Edema is also treated by a combination
of laser treatment and Triamcinolonacetonide.
After a decrease in macular edema caused by the Triamcinolonacetonide, the
effect from the laser can be achieved with less laser energy. Except for an
increase in visual acuity, this is also a way to limit scotomas caused by the
laser treatment and to decrease the need for retreatments with
Triamcinolonacetonide.
Instead of intravitreal administration, Triamcinolonacetonide can also be
injected sub-Tenon. This form of administration has less side-effects, but the
intraoculair availability is less than with the direct intravitreal injection.
At present laser treatment is performed in combination with either sub-Tenon or
intravitreal administration of Triamcinolonacetonide, but there is no study
that compares the results of these two methods.
Study objective
To show in a prospective randomised study if intravitreal injection of
Triamcinolonacetonide combined with Macula Grid Laser gives a better increase
in visual acuity and/or decrease in macular edema than Macula Grid Laser
combined with sub-Tenon Triamcinolonacetonide injection.
Study design
Prospective randomized interventional study with two groups.
Intervention
Group 1: Posterior sub-Tenon injection of Triamcinolonacetonide (20 mg in 0,5
ml) followed after 1 month by Macula Grid Laser (Argon Green laser).
Group 2: Intravitreal injection of Triamcinolonacetonide (10 mg in 0.1 ml)
followed after 1 month by Macula Grid Laser (Argon Green laser).
Study burden and risks
The burden and risks for the patient are equal to the treatment outside this
study, except for one extra venous tap (8ml). Total amount of time needed for
treatment and follow up will be around 8 hours in group 1 and 10 hours in group
2. Burden and risks for group 2 are higher than for group 1 because of the
intravitreal administration of the Triamcinolonacetonide in group 2.
Postbus 9101
6500 HB Nijmegen
Nederland
Postbus 9101
6500 HB Nijmegen
Nederland
Listed location countries
Age
Inclusion criteria
Age > 18 jaar
Diabetes Mellitus I or II
Clinically Significant macular Edema (< 1 year; mainly diffuse leakage on fluorescein angiogram)
Best corrected visual acuity 0.1 tot 0.4
HbA1C < 10.0
Blood pressure < 160/100 mm Hg
Intraocular pressure < 21 mm Hg
Exclusion criteria
Mainly focal leakage from microaneurysms
Mainly cystoid leakage
Proliferative Diabetic Retinopathy
Previous Macula Gridlaser
Panretinal photocoagulation < 6 months before inclusion
Preretinal or vitreous hemorrhage
Tractional retinal detachment
Significant media opacities obscuring evaluation and treatment of macula
Iris neovascularisations
Preëxistent amblyopia with VA < 0.2
Previous vitreoretinal surgery
Cataractsurgery < 6 months before inclusion
Intraocular pressure > 22 mm Hg
Glaucoma and/or steroïdresponder
Age related macula degeneration, uveïtis
Vitreomacular traction and/or macula pucker (fundoscopically and/or OCT)
Macula ischaemia (enlargement or irregular foveal avascular zone and/or 6 clock hours of macular capillary nonperfusion on fluorescein angiography)
Other ocular disease where intraocular surgery is needed.
Chronic renal failure with need for dialysis or renal transplant
Allergy for Triamcinolonacetonide
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2006-000884-27-NL |
| CCMO | NL12046.091.06 |