Condition category
Eye Diseases
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
04/11/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr G S Baarsma

ORCID ID

Contact details

Oogziekenhuis Rotterdam
Schiedamsevest 180
Rotterdam
3011 BH
Netherlands
+31 (0)10 401 7777
Baarsma@oogziekenhuis.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

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

Study information

Scientific title

Acronym

Study hypothesis

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

Received from the local medical ethics committee

Study design

Randomised, double blind, placebo controlled, parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Condition

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 names

Sandostatin® LAR

Primary outcome measures

1. Visual acuity and contrast sensitivity
2. Decrease in macular oedema
3. Arrest of neovascularisation (FAG)

Secondary outcome measures

No secondary outcome measures

Overall trial start date

02/02/2000

Overall trial end date

21/08/2003

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

120 (study closed, analysis and publication in progress)

Participant 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

Recruitment start date

02/02/2000

Recruitment end date

21/08/2003

Locations

Countries of recruitment

Netherlands

Trial participating centre

Oogziekenhuis Rotterdam
Rotterdam
3011 BH
Netherlands

Sponsor information

Organisation

Rotterdam Eye Hospital (Oogziekenhuis Rotterdam) (The Netherlands)

Sponsor details

Schiedamsevest 180
Rotterdam
3011 BH
Netherlands
+31 (0)10 401 77 77
info@oogziekenhuis.nl

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Industry

Funder name

Novartis Pharma B.V. (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes