EXTEND III - Efficacy and Safety of Ranibizumab in Patients With Subfoveal Choroidal Neovasculari⦠(NCT00470678) | Clinical Trial Compass
CompletedPhase 3
EXTEND III - Efficacy and Safety of Ranibizumab in Patients With Subfoveal Choroidal Neovascularization (CNV) Secondary to Age-related Macular Degeneration (AMD)
South Korea, Taiwan95 participantsStarted 2007-06
Plain-language summary
This study will evaluate efficacy and safety for monthly ranibizumab 0.5 mg intravitreal injections in Asian patients with subfoveal choroidal neovascularization secondary to age-related macular degeneration.
Who can participate
Age range50 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male or female Asian patients 50 years of age or greater.
* Patients with primary or recurrent subfoveal CNV secondary to AMD, including those with predominantly classic, minimally classic or active occult lesions with no classic component.
* Patients who have a BCVA score between 73 and 24 letters (approximately 20/40 to 20/320 Snellen equivalent), inclusively, in the study eye.
* Total area of CNV (including both classic and occult components) encompassed within the lesion must be \>= 50% of the total lesion area
* Total lesion area must be \<= 12 disc areas
Exclusion Criteria:
* Patients who have in the fellow eye a Snellen equivalent below 20/200
* Presence of angioid streaks, presumed ocular histoplasmosis syndrome, myopia (exceeding -8 diopters), or CNV secondary to causes other than AMD in the study eye
* Subfoveal fibrosis or atrophy in the study eye
* Total area of CNV (including both classic and occult components) encompassed within the lesion must be \>= 50% of the total lesion area
* Total lesion area must be \<= 12 disc areas
* Vitreous hemorrhage, retinal tear or history of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the study eye.
* Active, or history of, ocular inflammation or infection in the study eye within the last 30 days prior to screening.
* Uncontrolled glaucoma in the study eye
* Treatment in the study eye with verteporfin, external-beam radiation therapy, subfoveal focal laser photocoagulation, vitrectā¦
What they're measuring
1
Mean change in best-corrected visual acuity (BCVA) from Baseline, Month 4 and Month 12 as assessed with ETDRS (Early Treatment for Diabetic Retinopathy Study)-like charts at a distance of four meters