Overview

Comparison of Treatment Regimens Using Ranibizumab: Intensive (Resolution of Intra- and Sub-retinal Fluid) vs Relaxed (Resolution of Intra-retinal Fluid and/or Sub-retinal Fluid >200µm at the Foveal Centre)

Status:
Completed
Trial end date:
2017-02-28
Target enrollment:
0
Participant gender:
All
Summary
To evaluate and compare two individualised ranibizumab treatment regimens, differentiated by the definition of disease activity, which determines the treatment interval until the next injection. The results will be used to generate recommendations about ranibizumab treatment when using an 'inject and extend' approach to maximise patient outcomes, while reducing the need for potentially unnecessary intravitreal injections. This study will also investigate if genotypic expression influences response to intravitreal injections of ranibizumab between the two treatment arms. The study hypothesis is that intravitreal ranibizumab when administered to resolve IRF (and/or SRF >200 μm at the foveal centre) results in visual acuity benefit that is not clinically worse than intravitreal ranibizumab when administered to completely resolve both IRF and SRF in patients with wet AMD
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Novartis Pharmaceuticals
Treatments:
Ranibizumab
Criteria
Inclusion Criteria:

1. Diagnosis of subfoveal CNV secondary to wet AMD without restriction of lesion size,
with visual impairment being exclusively due to an active wet AMD lesion. Active
lesions will be characterised by any of the following: abnormal retinal thickness,
with evidence of intraretinal, subretinal or sub-pigment epithelial fluid
accumulation, confirmed by OCT; presence of intraretinal or subretinal haemorrhage;
new leakage shown on a FA; CNV enlargement on FA unless solely due to dry, fibrotic
staining; visual acuity deterioration considered likely to represent CNV.

2. BCVA score at both Screening and Baseline must be 23 letters or more as measured by
the Early Treatment Diabetic Retinopathy Study (ETDRS) logMAR charts (a Snellen visual
acuity or equivalent of 20/320 or more may be used as an alternative at Screening).

Exclusion Criteria:

1. Any active periocular or ocular infection or inflammation (e.g., blepharitis,
conjunctivitis, keratitis, scleritis, uveitis, endophthalmitis) at the time of
Screening or Baseline.

2. Uncontrolled glaucoma (intraocular pressure [IOP] ≥30 mm Hg on medication) at the time
of Screening or Baseline.

3. Neovascularisation of the iris or neovascular glaucoma at the time of Screening or
Baseline.

4. Visually significant cataract, aphakia, severe vitreous haemorrhage, rhegmatogenous
retinal detachment, proliferative diabetic retinopathy or CNV of any cause other than
wet AMD at the time of screening and baseline.

5. Structural damage within 0.5 disc diameter of the centre of the macula (e.g.,
vitreomacular traction, epiretinal membrane, scar, laser burn, foveal atrophy) at the
time of screening that in the investigator's opinion could preclude visual function
improvement with treatment.

6. Treatment with any anti-angiogenic drugs (including any anti-VEGF agents) prior to
Baseline in study eye (allowed in fellow eye).

7. Any intraocular procedure (including Ytrium-Aluminium- Garnet capsulotomy) within 2
months prior to Baseline or anticipated within the next 6 months following Baseline in
th study eye (allowed in fellow eye).

Other protocol-defined inclusion/exclusion criteria may apply.