EXTEND III - Efficacy and Safety of Ranibizumab in Patients With Subfoveal Choroidal Neovascularization (CNV) Secondary to Age-related Macular Degeneration (AMD)
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ClinicalTrials.gov Identifier: NCT00470678 |
Recruitment Status :
Completed
First Posted : May 8, 2007
Last Update Posted : November 18, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Choroidal Neovascularization Age-Related Macular Degeneration | Drug: ranibizumab | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 95 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official 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 |
Study Start Date : | June 2007 |
Actual Primary Completion Date : | November 2008 |
Actual Study Completion Date : | November 2008 |

Arm | Intervention/treatment |
---|---|
Experimental: 1
Ranibizumab
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Drug: ranibizumab
Other Name: Lucentis, RFB002 |
- 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 ]
- 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 ]

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Ages Eligible for Study: | 50 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00470678
Korea, Republic of | |
Novartis Investigative Site | |
Daegu, Korea, Republic of | |
Novartis Investigative Site | |
Pusan, Korea, Republic of | |
Novartis Investigative site | |
Seoul, Korea, Republic of | |
Taiwan | |
Novartis Investigative Site | |
Kaohsiung, Taiwan | |
Novartis Investigative Site | |
LinKou, Taiwan | |
Novartis Investigative site | |
Taipei, Taiwan |
Study Chair: | Novartis Pharma | Novartis |
Responsible Party: | Novartis |
ClinicalTrials.gov Identifier: | NCT00470678 |
Other Study ID Numbers: |
CRFB002A2304 |
First Posted: | May 8, 2007 Key Record Dates |
Last Update Posted: | November 18, 2016 |
Last Verified: | November 2016 |
Age-related macular degeneration AMD Ranibizumab Anti-VEGF choroidal |
neovascularization CNV Asian patients Korea Taiwan associated |
Macular Degeneration Choroidal Neovascularization Neovascularization, Pathologic Retinal Degeneration Retinal Diseases Eye Diseases Metaplasia Pathologic Processes Choroid Diseases |
Uveal Diseases Ranibizumab Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors Antineoplastic Agents |