Combined (repeated) laser photocoagulation prolongs time to failure compared to anti-VEGF monotherapy.
ID
Bron
Verkorte titel
Aandoening
Diabetic macular edema
Ondersteuning
Rotterdam Ophthalmic Institute
PO Box 70030, NL-3000 LM Rotterdam
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Proportion of treatment failures at 72 weeks, with treatment failure defined at 24 weeks as < 50 micron decrease in CFT and no improvement in VA, i.e. 1 or more letters loss in VA, compared to baseline. After the 24 week visit failure of treatment is defined as > 50 micron increase in CFT, irrespective of VA, compared to week 24.
Achtergrond van het onderzoek
Rationale:
Diabetes mellitus is a worldwide epidemic with an anticipated prevalence of 4.4% in 2030. Diabetic macular edema (DME) often leads to severe visual acuity loss. It is expected that in 2025 there will be about 250.000 patients with DME in the Netherlands, with an annual incidence of 12.500 cases. Because of evident visual gain, current clinical treatment standards have switched from primary laser photocoagulation to (bi)monthly intravitreal anti-VEGF injections. It is conjectured that the outcome of photo¬coagulation therapy combined with intravitreal anti-VEGF injections is at least equivalent in visual outcome and, at the same time, helps to reduce the number of required intravitreal injections. With that, patient burden may become less and the growing demand on health care resources can be alleviated.
Objective:
To demonstrate that combined (repeated) laser photocoagulation prolongs time to failure compared to anti-VEGF monotherapy.
Study design:
Randomized, three-arms, double blind, comparative clinical trial.
Study population:
Patients with DME.
Intervention:
Laser photocoagulation, intravitreal anti-VEGF injection.
Main study parameters/endpoints:
Proportion of failures to treatment at 72 weeks.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
Risks do not exceed those of regular DME treatment. Patients in combination groups may benefit from the additional treatment effect accomplished by laser photocoagulation. Visits required for this study coincide with the routine treatment/control schedule for DME, and study assessments are largely the same as in normal monitoring. Therefore, burden is considered to be negligible.
Doel van het onderzoek
Combined (repeated) laser photocoagulation prolongs time to failure compared to anti-VEGF monotherapy.
Onderzoeksopzet
Weeks 0, 1, 6, 12, 18, 19, 24, 30, 36, 48, 60, 72.
Onderzoeksproduct en/of interventie
Group 1: Repeated SHAM;
Group 2: LASER followed by SHAM;
Group 3: Repeated LASER.
All participants will receive four intravitreal anti-VEGF injections during the first period (week 0 till 19) and dependant on the study arm zero, one or two lasertreatments.
Publiek
Schiedamsevest 180,
T. Missotten
Rotterdam 3011 BH
The Netherlands
010 401777
t.missotten.oogziekenhuis.nl
Wetenschappelijk
Schiedamsevest 180,
T. Missotten
Rotterdam 3011 BH
The Netherlands
010 401777
t.missotten.oogziekenhuis.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Age ¡Ý 18 years;
2. Able to read and sign the written informed consent;
3. Diagnosis of DME, based on ETDRS criteria and confirmed by macular edema on optical coherence tomography (OCT, Heidelberg Spectralis), defined as CFT ¡Ý 340 micron (see Section 7.1 for argumentation for chosen cut-off value);
4. VA loss due to DME, with VA being between 45 and 85 letters as measured on ETDRS chart (Snellen decimal equivalent: 0.08 ¡§C 0.63);
5. If both eyes are eligible, the eye with the highest CFT will be selected as the study eye. If both eyes have equal CFT, the eye with the most recent record of presence of DME will be selected as the study eye. The fellow eye will receive treatment according to the current standard of care at the investigator's discretion.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Previous laser photocoagulation therapy within the last 6 months;
2. Previous anti-VEGF therapy (Avastin, Lucentis, Eylea, or any investigational anti-VEGF drug) within the last 3 months;
3. Previous subtenon's or intravitreal triamcinolone injection within the last 6 months;
4. Steroid implants of any kind within the last 3 years;
5. Macular ischemia confirmed by fluorescein angiography (FA);
6. Vitreoretinal traction or epiretinal membranes with the potential of macular structural damage and function loss, confirmed by OCT;
7. Other eye conditions affecting VA prognosis, including pre-existent (deep) amblyopia;
8. Any ocular surgery/intervention within last three months before enrollment;
9. Any ocular surgery/intervention anticipated during the course of the study;
10. Ocular opacities hampering adequate imaging of the posterior pole;
11. Poor control of DM with glycated hemoglobin (HbA1c) of ¡Ý 86% in last 6 months;
12. Allergy to fluorescein or anti-VEGF, or any of its preservatives;
13. Pregnancy;
14. Non-Caucasian or Asian descent.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL3584 |
| NTR-old | NTR3742 |
| Ander register | Rotterdam Eye Hospital / CCMO : OZR-2011-17 / NL41998.078.12; |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |