Exudative age-related macular degeneration
Conditions
Interventions
Three monthly intravitreal injections and additional injections as needed during one year of:
Group A: 1.25 mg bevacizumab
Group B: 0.5 mg ranibizumab
Sponsors
Maastricht University Medical Centre + (MUMC+)
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients 60 years of age or higher. 2. Patients with primary or recurrent sub-, juxta- or extrafoveal CNV secondary to AMD, including those with RAP, that may benefit from anti-VEGF treatment in the opinion of the investigator. 3. The total area of CNV (including both classic and occult components) encompassed within the lesion must be more or equal to 30% of the total lesion area. 4. The total lesion area should be < 12 disc areas. 5. A best corrected visual acuity (BCVA) score between 78 and 20 letters (approximately 0,63-0,05 Snellen equivalent) in the study eye. 6. Willing and able to give written informed consent according to legal requirements, and who have signed the consent form prior to initiation of any study procedure.
Exclusion criteria
Exclusion criteria: 1. Ocular treatment with anti-angiogenic drugs in the last 2 months or Triamcinolone or Prednisolone in the last 6 months. 2. Laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within one month preceding Baseline. 3. Patients with angioid streaks or precursors of CNV in either eye due to other causes, such as ocular histoplasmosis, trauma, or pathologic myopia. 4. Spherical equivalent of refractive error in the study eye demonstrating more than – 8 dioptres of myopia. 5. Cataract extraction within three months preceding Baseline. 6. IOP >25 mm Hg 7. Active intraocular inflammation in the study eye. 8. Vitreous haemorrhage obscuring view of the posterior pole in the study eye. 9. Presence of a retinal pigment epithelial tear involving the macula in the study eye. 10. Subretinal haemorrhage in the study eye if the size of the haemorrhage is > 70% of the lesion 11. Subfoveal fibrosis or atrophy in the study eye. 12. History of hypersensitivity or allergy to fluorescein. 13. Inability to obtain fundus photographs, fluorescein angiograms or OCT’s of sufficient quality to be analyzed and graded by the Central Reading Centre. 14. Systemic disease with a life expectancy shorter than the duration of the study. 15. Inability to adhere to the protocol with regard to injection and follow-up visits. 16. Legally incompetent adult
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change in best-corrected visual acuity (BCVA) in the study eye from baseline to Month 12 assessed with ETDRS-like VA charts at an initial distance of four meter. The VA will be measured at baseline and once a month during one year. | — |
Secondary
| Measure | Time frame |
|---|---|
| - The proportion of patients with a loss of BVCA less than 15 letters from Baseline at 12 months (responders) - The proportion of patients with a loss or gain of BVCA less than 15 letters from Baseline at 12 months (stabilizers) - The proportion of patients with 15 letters loss or more of BCVA from Baseline at 12 months (losers) - The proportion of patients with 15 letters gain or more of BCVA from Baseline at 12 months (gainers) - The change in quality of life and utility from baseline to 3, 6 and12 months - The incidence of fluorescein leakage at 12 months as well as the change in total area of CNV, total area of leakage from CNV, and total lesion area from baseline at 12 months - Absolute and percent change in retinal thickness, as measured by optical coherence tomography (OCT) at 4 and 12 months - Proportion of dropouts before the final 12 months assessments - Proportion of non-responders at the 4 month assessment - The occurrence of (serious) adverse events during the 12 months of the study - Costs of the two treatment stategies. | — |
Contacts
Public ContactJ.S.A.G. Schouten
Maastricht University Hospital Department of Ophthalmology P.O. Box 5800
Outcome results
None listed