A pillot study to examine the safety and efficacy of intravitreal ranubizimab/dexamethasone administration and oral minocycline in addition to Visudyne (verteporfin) photdynamic therapy for subfoveal choroidal neovascularization secondary to age related macular degeneration degeneration: an open label trial. - Combination Therapy for the Treatment of Neovascular AMD

Phase 1

• Conditions: Age related macular degeneration; MedDRA version: 9.1Level: LLTClassification code 10064930Term: Age-related macular degeneration

• Registration Number: EUCTR2006-004292-35-GB
• Lead Sponsor: Kings College Hospital NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01-09
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1.The patient must be willing to give written informed consent.
2. The patient must be able to undertake the necessary tests and treatment and be willing to be followed up.
3. Age 50 years or older.
4. Clinical diagnosis of AMD.
5. Subfoveal CNV on fluorescein angiography.
6. Log MAR best corrected visual acuity of 24-73 letters on EDTRS chart

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Inability to understand or sign consent form.
2. The patient has a current medical condition or history of a medical condition that would be likely to preclude scheduled study visits such as unstable angina, dialysis, and active cancer.
3. Patient has a current ophthalmic condition or history of an ophthalmic condition that might compromise the assessment of the treatment such as diabetic retinopathy, uveitis, amblyopia, ischaemic optic neuropathy.
4. Signs of a myopic retina or refraction of > -8 dioptres in their current or any previous glasses prescription.
5. Signs of other retinal conditions that may have caused the CNV such as angioid streaks, choroidal rupture, and old chorio-retinitis.
6. Open angle glaucoma.
7. At increased risk of developing glaucoma such as having; pigment dispersion syndrome or pseudoexfoliation
8. Unable to have a good quality fluorescein angiogram taken e.g. due to head tremor or media opacity.
9. Known hypersensitivity to fluorescein or any of the study medications.
10. Previous treatment for a retinal detachment.
11. Judged by the examining clinician to be at increased risk of retinal detachment due to weaknesses in the peripheral retina.
12. Previous photodynamic therapy or other therapy for a CNV including argon laser treatment.
13. Patient is currently participating or has participated in a clinical trial that utilized an investigational drug or treatment within 30 days prior to enrolment to this study.
14. On anticoagulation therapy such as warfarin, with the exception of aspirin and other anti-platelet therapy.
15. Exclusion of women of childbearing potential
16. Exclusion of pregnant or lactating women

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the safety and effectiveness of the combined therapy of intravitreal ranubizumab/ dexamethasone , oral minocycline and verteporfin photodynamic therapy for subfoveal choroidal neovascularisation (CNV) secondary to age-related macular degeneration (AMD).;Secondary Objective: ;Primary end point(s): Primary Endpoint<br>•Evaluate the changes in visual acuity from baseline at 12 months in patients treated with intravitreal ranibizumab in combination with verteporfin photodynamic therapy. <br>