Sandostatin LAR administered i.m. at a dose of 20 mg once per 4 weeks during 6 months, to patients with exudation in AMD, maintains stable visual acuity, and decreases macular edema and neovascularisation.
ID
Bron
Verkorte titel
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Visual acuity and contrast sensitivity,
decrease in macular edema and arrest of neovascularisation (FAG).
Achtergrond van het onderzoek
N/A
Doel van het onderzoek
Sandostatin LAR administered i.m. at a dose of 20 mg once per 4 weeks during 6 months, to patients with exudation in AMD, maintains stable visual acuity, and decreases macular edema and neovascularisation.
Onderzoeksopzet
N/A
Onderzoeksproduct en/of interventie
Intramuscular injection of 20 mg Sandostatin LAR or standard 0.9% saline solution once every 4 weeks during 6 months.
Publiek
Schiedamsevest 180
G.S. Baarsma
Schiedamsevest 180
Rotterdam 3011 BH
The Netherlands
+31 (0)10 4017777
Baarsma@oogziekenhuis.nl
Wetenschappelijk
Schiedamsevest 180
G.S. Baarsma
Schiedamsevest 180
Rotterdam 3011 BH
The Netherlands
+31 (0)10 4017777
Baarsma@oogziekenhuis.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Recent history of visual acuity decrease (< 6 weeks prior to study start) related to exudative ARMD;
2. Clinical signs of ARMD (i.e. drusen and/or RPE changes);
3. Age > 60 years;
4. FAG (taken within 96 hrs after randomization) documenting fluorescin leakage from a well-demarcated classic or mixed CNV within 200 ¦Ìm of the center of the FAZ (size < 3.5 disc areas);
5. Best corrected visual acuity for distance in study eye ¡Ý 0.125 (Snellen chart) determined within 96 hrs after randomization.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Diabetes mellitus;
2. Symptomatic cholelithiasis;
3. Use of anticoagulants;
4. Malignancy;
5. Active hepatitis or clinically significant liver disease or dysfunction;
6. Platelets < 1011/L;
7. Hb < 5.5 mmol/L;
8. Concomittant surgical intervention, laser coagulation, acetazolamide, systemic steroids or immunorepressive therapy,
tear of the RPE;
9. Vitelliform-like lesion of the outer retina or central serous retinopathy;
10. Additional ocular disease which has irreversibly compromised, or is likely to compromise during follow-up, visual acuity of the study eye;
11. Inabillity to obtain photographs to document choroidal neovascularization,
history of CNV treatment in study eye;
12. Participation in another ophthalmic clinical trial;
13. Intraocular surgery within previous 2 months;
14. Nd:YAG capsulometry within last month.
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 | NL293 |
NTR-old | NTR331 |
Ander register | : CSMS995IB01; (local study number: OZR-1999-14) |
ISRCTN | ISRCTN16381123 |