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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.

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.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON25954
Enrollment
120
Registered
2005-10-11
Start date
2000-02-02
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intramuscular injection of 20 mg Sandostatin LAR or standard 0.9% saline solution once every 4 weeks during 6 months.

Sponsors

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1. Recent history of visual acuity decrease ( 60 years; 4. FAG (taken within 96 hrs after randomization) documenting fluorescin leakage from a well-demarcated classic or mixed CNV within 200 ¦Ìm of the center of the FAZ (size < 3.5 disc areas); 5. Best corrected visual acuity for distance in study eye ¡Ý 0.125 (Snellen chart) determined within 96 hrs after randomization.

Exclusion criteria

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 < 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.

Design outcomes

Primary

MeasureTime frame
Visual acuity and contrast sensitivity, decrease in macular edema and arrest of neovascularisation (FAG).—

Contacts

Public ContactG.S. Baarsma

Oogziekenhuis Rotterdam, Schiedamsevest 180

Baarsma@oogziekenhuis.nl+31 (0)10 4017777

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)