EXTEND III - Efficacy and Safety of Ranibizumab in Patients With Subfoveal Choroidal Neovascularization (CNV) Secondary to Age-related Macular Degeneration (AMD)

• Register: ClinicalTrials.gov
• Last refreshed on: 28 November 2016
• Main ID: NCT00470678
• Date of registration: 07/05/2007
• Prospective Registration: Yes
• Primary sponsor: Novartis
• Public title: EXTEND III - Efficacy and Safety of Ranibizumab in Patients With Subfoveal Choroidal Neovascularization (CNV) Secondary to Age-related Macular Degeneration (AMD)
• Scientific title: An Open-label, Multicenter Study to Evaluate the Efficacy and Safety of Ranibizumab (0.5 mg) in Patients With Subfoveal Choroidal Neovascularization Secondary to Age-related Macular Degeneration Over 12 Months
• Date of first enrolment: June 2007
• Target sample size: 95
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00470678
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

Korea, Republic of, Taiwan

Contacts

• Name: Novartis Pharma
• Affiliation: Novartis

Key inclusion & exclusion criteria

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, vitrectomy, submacular surgery, or
transpupillary thermotherapy within 30 days prior to screening

- Previous treatment with anti-angiogenic drugs (pegaptanib, ranibizumab, bevacizumab,
anecortave acetate, corticosteroids, protein kinase C inhibitors, squalamine, siRNA,
VEGF-Trap etc.) for neovascular AMD in the study eye. Treatment of the fellow eye is
permitted if administered > 30 days before screening.

- History of intraocular surgery in the study eye including pars plana vitrectomy,
except for uncomplicated cataract surgery more than 60 days prior to screening

- History of YAG laser posterior capsulotomy in the study eye within 30 days prior to
screening



Age minimum: 50 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Age-Related Macular Degeneration

Choroidal Neovascularization

Intervention(s)

Drug: ranibizumab

Primary Outcome(s)

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 [Time Frame: Baseline, Month 4 and Month 12]

Secondary Outcome(s)

Changes in the retinal structure from baseline as assessed by fundus photography and fluorescein angiography, Month 4 and Month 12 [Time Frame: Month 4 and Month 12]

Safety by rates of adverse events and serious adverse events, ophthalmic examinations, tonometry, and vital signs, baseline, Month 4, Month 6 and Month 12 [Time Frame: Baseline, Month 4, Month 6 and Month 12]

Secondary ID(s)

CRFB002A2304

Source(s) of Monetary Support

Please refer to primary and secondary sponsors