Exudative senile macular degeneration of the retina MedDRA version: 9.1 Level: LLT Classification code 10015902 Term: Exudative senile macular degeneration of retina
Conditions
Interventions
Sponsors
Royal Liverpool & Broadgreen University hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion into the study is judged on the clinical examination, the lesion characteristics as defined by interpretation of fluorescein angiography (FFA) and the best corrected visual acuity (BCVA). The following lesions should be included: Exudative age-related macular degeneration in first or second eyes with angiographic signs of active subfoveal or juxtafoveal choroidal neovascularization (CNV) on FFA and a BCVA of =35 ETDRS letters (6/60) or better. Lesions characterised as the following on angiography: • Classic CNV • Predominantly classic CNV • Occult CNV • Minimally classic CNV • Retinal pigment epithelial detachments • Retinal angiomatous proliferations (RAP) • Classic or occult CNV with blood > 50% of the lesion but no blood in the centre of the presumed foveal avascular zone (FAZ) • Classic, predominantly classic, minimally classic and occult CNV within 6 months after initiation of PDT treatment, a maximum of 2 PDT treatments and a loss of BCVA of =10 letters compared to baseline before PDT, irrespective of the angiographic picture • Classic, predominantly classic, minimally classic and occult CNV within 3 months after initiation of Macugen treatment, a maximum of 2 Macugen injections and a loss of BCVA of =10 letters compared to baseline before Macugen, irrespective of the angiographic lesion characteristics • Recurrent CNV following laser photocoagulation, irrespective of the angiographic picture 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
Exclusion criteria: Exudative AMD with angiographic signs of subfoveal or juxtafoveal choroidal neovascularization (CNV) on FFA and: • Extrafoveal CNV (should undergo laser photocoagulation or PDT) • Retinal pigment epithelial tears • Lesion with blood > 50% of the whole lesion and blood in the centre of the presumed FAZ • Clinical and angiographic signs of fibrosis >50% of the lesion • Visual acuity 100 or systolic blood pressure >200 as determined by the mean of three separate measurements at baseline. 3. Patients with unstable medical status in particular cardiovascular disease which in the opinion of the investigator would preclude patient’s participation in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: Assess the value of new imaging techniques in detecting a response to treatment. ;Primary end point(s): The main endpoint of the study is change in best corrected visual acuity (BCVA) compared to baseline. This will be assessed at 18 weeks and 54 weeks following first treatment. ;Main Objective: Investigate the dose response and retreatment criteria for the intravitreal application of Bevacizumab (Avastin) in the treatment of exudative age related macular degeneration (AMD). | — |
Countries
United Kingdom
Outcome results
None listed