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Randomized, placebo controlled, patient and observer masked study to evaluate the efficacy of treatment with Sandostatin LAR 20 mg i.m. or placebo every 4 weeks during 6 months in 120 patients with exudative age-related macular degeneration.


- candidate number0
- NTR NumberNTR331
- ISRCTNISRCTN16381123
- Date ISRCTN created20-dec-2005
- date ISRCTN requested18-okt-2005
- Date Registered NTR11-okt-2005
- Secondary IDsCSMS995IB01; (local study number: OZR-1999-14) 
- Public TitleRandomized, placebo controlled, patient and observer masked study to evaluate the efficacy of treatment with Sandostatin LAR 20 mg i.m. or placebo every 4 weeks during 6 months in 120 patients with exudative age-related macular degeneration.
- Scientific TitleRandomized, placebo controlled, patient and observer masked study to evaluate the efficacy of treatment with Sandostatin LAR 20 mg i.m. or placebo every 4 weeks during 6 months in 120 patients with exudative age-related macular degeneration.
- ACRONYMN/A
- hypothesisSandostatin 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.
- Healt Condition(s) or Problem(s) studiedExudative age-related macula degeneration (ARMD)
- Inclusion criteria1. 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 m of the center of the FAZ (size < 3.5 disc areas);
5. Best corrected visual acuity for distance in study eye 0.125 (Snellen chart) determined within 96 hrs after randomization.
- Exclusion criteria1. 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.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 2-feb-2000
- planned closingdate21-aug-2003
- Target number of participants120
- InterventionsIntramuscular injection of 20 mg Sandostatin LAR or standard 0.9% saline solution once every 4 weeks during 6 months.
- Primary outcomeVisual acuity and contrast sensitivity, decrease in macular edema and arrest of neovascularisation (FAG).
- Secondary outcomeN/A
- TimepointsN/A
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESDrs. G.S. Baarsma
- CONTACT for SCIENTIFIC QUERIESDrs. G.S. Baarsma
- Sponsor/Initiator Oogziekenhuis Rotterdam (OZR)
- Funding
(Source(s) of Monetary or Material Support)
Novartis Pharma B.V.
- PublicationsT.Missotten, G.S. Baarsma, R.W. A. M. Kuijpers, P.M. van Hagen. Somatostatin Analog for the Treatment of Exsudative Age Related Macular Degeneration: A Randomised Trial. ARVO 2007.
- Brief summaryN/A
- Main changes (audit trail)
- RECORD11-okt-2005 - 4-jun-2008


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