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
Secondary identifying numbers	CSMS995IB01; (local study number: OZR-1999-14); NTR331

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

Oogziekenhuis Rotterdam
Schiedamsevest 180
Rotterdam
3011 BH
Netherlands

Phone	+31 (0)10 401 7777
Email	Baarsma@oogziekenhuis.nl

Study information

Study design	Randomised, double blind, placebo controlled, parallel group trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Treatment
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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Sandostatin® LAR
Primary outcome measure	1. Visual acuity and contrast sensitivity 2. Decrease in macular oedema 3. Arrest of neovascularisation (FAG)
Secondary outcome measures	No secondary outcome measures
Overall study start date	02/02/2000
Completion date	21/08/2003

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	Both
Target number of participants	120 (study closed, analysis and publication in progress)
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

Sponsor information

Rotterdam Eye Hospital (Oogziekenhuis Rotterdam) (The Netherlands)
Hospital/treatment centre

Schiedamsevest 180
Rotterdam
3011 BH
Netherlands

Phone	+31 (0)10 401 77 77
Email	info@oogziekenhuis.nl
"ROR"	https://ror.org/02hjc7j46

Funders

Funder type

Industry

Novartis Pharma B.V. (The Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan