Randomised, placebo controlled, patient and observer masked study to evaluate the efficacy of treatment with Sandostatin® LAR 20 mg intramuscularly (i.m.) or placebo every 4 weeks during 6 months in 120 patients with exudative age-related macular degeneration
| ISRCTN | ISRCTN16381123 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16381123 |
| Protocol serial number | CSMS995IB01; (local study number: OZR-1999-14); NTR331 |
| Sponsor | Rotterdam Eye Hospital (Oogziekenhuis Rotterdam) (The Netherlands) |
| Funder | Novartis Pharma B.V. (The Netherlands) |
- Submission date
- 20/12/2005
- Registration date
- 20/12/2005
- Last edited
- 04/11/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr G S Baarsma
Scientific
Scientific
Oogziekenhuis Rotterdam
Schiedamsevest 180
Rotterdam
3011 BH
Netherlands
| Phone | +31 (0)10 401 7777 |
|---|---|
| Baarsma@oogziekenhuis.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised, double blind, placebo controlled, parallel group trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | Sandostatin® LAR administered intramuscularly (i.m.) at a dose of 20 mg once per 4 weeks during 6 months, to patients with exudation in age-related macular degeneration (AMD), maintains stable visual acuity, and decreases macular oedema and neovascularisation. |
| Ethics approval(s) | Received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | Exudative age-related macula degeneration (AMD) |
| Intervention | Intramuscular injection of 20 mg Sandostatin® LAR or standard 0.9% saline solution once every 4 weeks during 6 months. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Sandostatin® LAR |
| Primary outcome measure(s) |
1. Visual acuity and contrast sensitivity |
| Key secondary outcome measure(s) |
No secondary outcome measures |
| Completion date | 21/08/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | All |
| Target sample size at registration | 120 |
| Key inclusion criteria | 1. Recent history of visual acuity decrease (less than 6 weeks prior to study start) related to exudative AMD 2. Clinical signs of AMD (i.e. drusen and/or retinal pigment epithelium [RPE] changes) 3. Aged greater than 60 years 4. Fluorescein angiograms (FAG) (taken within 96 hours after randomisation) documenting fluorescein leakage from a well-demarcated classic or mixed choroidal neovascularisation (CNV) within 200 µm of the centre of the foveal avascular zone (FAZ) (size less than 3.5 disc areas) 5. Best corrected visual acuity for distance in study eye greater than or equal to 0.125 (Snellen chart) determined within 96 hours after randomisation |
| Key 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 less than 1011/L 7. Haemoglobin (Hb) less than 55 mmol/L 8. Concomitant surgical intervention, laser coagulation acetazolamide, systemic steroids or immunorepressive therapy 9. Tear of the RPE 10. Vitelliform-like lesion of the outer retina or central serous retinopathy 11. Additional ocular disease which has irreversibly compromised, or is likely to compromise during follow-up, visual acuity of the study eye 12. Inability to obtain photographs to document CNV 13. History of CNV treatment in study eye 14. Participation in another ophthalmic clinical trial 15. Intraocular surgery within previous two months 16. Neodymium-doped yttrium aluminium garnet (Nd:YAG) capsulometry within last month |
| Date of first enrolment | 02/02/2000 |
| Date of final enrolment | 21/08/2003 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Oogziekenhuis Rotterdam
Rotterdam
3011 BH
Netherlands
3011 BH
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
