No registrations found.
ID
Source
Brief title
Intervention
Outcome measures
Primary outcome
Visual acuity and contrast sensitivity,
decrease in macular edema and arrest of neovascularisation (FAG).
Secondary outcome
N/A
Background summary
N/A
Study objective
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.
Study design
N/A
Intervention
Intramuscular injection of 20 mg Sandostatin LAR or standard 0.9% saline solution once every 4 weeks during 6 months.
Schiedamsevest 180
G.S. Baarsma
Schiedamsevest 180
Rotterdam 3011 BH
The Netherlands
+31 (0)10 4017777
Baarsma@oogziekenhuis.nl
Schiedamsevest 180
G.S. Baarsma
Schiedamsevest 180
Rotterdam 3011 BH
The Netherlands
+31 (0)10 4017777
Baarsma@oogziekenhuis.nl
Inclusion criteria
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.
Exclusion criteria
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.
Design
Recruitment
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 |
---|---|
NTR-new | NL293 |
NTR-old | NTR331 |
Other | : CSMS995IB01; (local study number: OZR-1999-14) |
ISRCTN | ISRCTN16381123 |