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 degeneratio

Completed

• Conditions: Exudative age-related macula degeneration (AMD); Eye Diseases; macula degeneration

• Registration Number: ISRCTN16381123
• Lead Sponsor: Rotterdam Eye Hospital (Oogziekenhuis Rotterdam) (The Netherlands)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-12-20
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 120

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Visual acuity and contrast sensitivity<br>2. Decrease in macular oedema <br>3. Arrest of neovascularisation (FAG)

Secondary Outcome Measures

Name	Time	Method
o secondary outcome measures