AzTrials
AzTrials

Macular DegenerationPhase 3NCT00056836

A Study to Evaluate rhuFab V2 in Subjects With Minimally Classic or Occult Subfoveal Neovascular Macular Degeneration

A Phase 3 study testing rhuFab V2 (ranibizumab) in people with Macular Degeneration, run by Genentech, Inc..

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to determine whether injections of rhuFab V2 into the eye can prevent vision loss in patients with age-related macular degeneration, and also to evaluate the safety of this treatment. Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Macular Degeneration
What is being tested?
rhuFab V2 (ranibizumab)
How many people
720 participants
Where
No sites listed yet
Study dates
Mar 2003to Dec 2005
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed informed consent
  • Age >=50 years
  • Active primary or recurrent subfoveal choroidal neovascularization (CNV) lesions secondary to age-related macular degeneration (AMD) in the study eye
  • Lesions with occult CNV or with some classic CNV component are permissible. However, if classic CNV (well-demarcated hyperfluorescence boundaries in the early phase of the fluorescein angiogram) is present, the area of classic CNV must be <50% of the total lesion size.
  • The total area of CNV (including both classic and occult components) encompassed within the lesion must be >=50% of the total lesion area.
  • The total lesion area must be <=12 disc areas (DA) in size.
  • Best corrected visual acuity, using Early Treatment of Diabetic Retinopathy Study (ETDRS) charts, of 20/40 to 20/320 (Snellen equivalent) in the study eye

Who cannot join

  • Prior treatment with verteporfin, external-beam radiation therapy, or transpupillary thermotherapy (TTT) in the study eye
  • Treatment with verteporfin in the non-study eye less than 7 days preceding Day 0
  • Previous participation in a clinical trial (for either eye) involving anti-angiogenic drugs (pegaptanib, ranibizumab, anecortave acetate, protein kinase C inhibitors, etc.)
  • Previous intravitreal drug delivery (e.g., intravitreal corticosteroid injection or device implantation) in the study eye
  • Previous subfoveal focal laser photocoagulation in the study eye
  • Laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within 1 month preceding Day 0
Show all 31Show fewer
  • History of vitrectomy surgery in the study eye
  • History of submacular surgery or other surgical intervention for AMD in the study eye
  • Previous participation in any studies of investigational drugs within 1 month preceding Day 0 (excluding vitamins and minerals)
  • Subretinal hemorrhage in the study eye that involves the center of the fovea, if the size of the hemorrhage is either >=50% of the total lesion area or >=1 disc area in size
  • Subfoveal fibrosis or atrophy in the study eye
  • CNV in either eye due to other causes, such as ocular histoplasmosis, trauma, or pathologic myopia
  • Retinal pigment epithelial tear involving the macula in the study eye
  • Any concurrent intraocular condition in the study eye (e.g., cataract or diabetic retinopathy) that, in the opinion of the investigator, could either: (1) Require medical or surgical intervention during the 24-month study period to prevent or treat visual loss that might result from that condition, or (2) If allowed to progress untreated, could likely contribute to loss of at least 2 Snellen equivalent lines of best corrected visual acuity over the 24-month study period
  • Active intraocular inflammation (grade trace or above) in the study eye
  • Current vitreous hemorrhage in the study eye
  • History of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the study eye
  • History of idiopathic or autoimmune-associated uveitis in either eye
  • Infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye
  • Aphakia or absence of the posterior capsule in the study eye
  • Spherical equivalent of the refractive error in the study eye demonstrating more than -8 diopters of myopia
  • Intraocular surgery (including cataract surgery) in the study eye within 2 months preceding Day 0
  • Uncontrolled glaucoma in the study eye (defined as intraocular pressure >= 30 mmHg despite treatment with anti-glaucoma medication)
  • History of glaucoma filtering surgery in the study eye
  • History of corneal transplant in the study eye
  • Premenopausal women not using adequate contraception
  • History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect interpretation of the results of the study or render the subject at high risk for treatment complications
  • Current treatment for active systemic infection
  • History of allergy to fluorescein, not amenable to treatment
  • Inability to obtain fundus photographs or fluorescein angiograms of sufficient quality to be analyzed and graded by the central reading center
  • Inability to comply with study or follow up procedures

About this study

Official title: A Phase III, Multicenter, Randomized, Double Masked, Sham Injection-Controlled Study of the Efficacy and Safety of rhuFab V2 (Ranibizumab) in Subjects With Minimally Classic or Occult Subfoveal Neovascular Age-Related Macular Degeneration

The purpose of this study is to determine whether injections of rhuFab V2 into the eye can prevent vision loss in patients with age-related macular degeneration, and also to evaluate the safety of this treatment.

Being tested
rhuFab V2 (ranibizumab)
Keywords
AMD, Neovascular age-related macular degeneration
Medical subject headings
Macular Degeneration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • rhuFab V2 (ranibizumab)Drug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Mar 2003 (estimated)
  2. Study startMar 2003
  3. Study completionDec 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Masking
Double blind
Enrolment
720 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00056836
Sponsor's protocol ID
FVF2598g
Status last verified
May 2014
First submitted
24 Mar 2003
Last updated
16 May 2014
Results posted
No

Publications

  • Rosenfeld PJ, Brown DM, Heier JS, Boyer DS, Kaiser PK, Chung CY, Kim RY; MARINA Study Group. Ranibizumab for neovascular age-related macular degeneration. N Engl J Med. 2006 Oct 5;355(14):1419-31. doi: 10.1056/NEJMoa054481.

    PubMed 17021318

  • Suner IJ, Kokame GT, Yu E, Ward J, Dolan C, Bressler NM. Responsiveness of NEI VFQ-25 to changes in visual acuity in neovascular AMD: validation studies from two phase 3 clinical trials. Invest Ophthalmol Vis Sci. 2009 Aug;50(8):3629-35. doi: 10.1167/iovs.08-3225. Epub 2009 Feb 28.

    PubMed 19255158

  • Blodi BA, Domalpally A, Corkery E, Osborne A, Blotner S, Grzeschik SM, Gune S. Prevalence of Macular Atrophy in the MARINA Study of Ranibizumab versus Sham for Neovascular Age-Related Macular Degeneration. Ophthalmol Retina. 2023 Aug;7(8):661-671. doi: 10.1016/j.oret.2023.03.004. Epub 2023 Apr 22.

    PubMed 37086257

  • Mollan SP, Fu DJ, Chuo CY, Gannon JG, Lee WH, Hopkins JJ, Hughes C, Denniston AK, Keane PA, Cantrell R. Predicting the immediate impact of national lockdown on neovascular age-related macular degeneration and associated visual morbidity: an INSIGHT Health Data Research Hub for Eye Health report. Br J Ophthalmol. 2023 Feb;107(2):267-274. doi: 10.1136/bjophthalmol-2021-319383. Epub 2021 Sep 13.

    PubMed 34518162

  • Weinberg DV, Shapiro H, Ehrlich JS. Ranibizumab treatment outcomes in phakic versus pseudophakic eyes: an individual patient data analysis of 2 phase 3 trials. Ophthalmology. 2013 Jun;120(6):1278-82. doi: 10.1016/j.ophtha.2012.11.042. Epub 2013 Feb 28.

    PubMed 23453513

  • Xu L, Lu T, Tuomi L, Jumbe N, Lu J, Eppler S, Kuebler P, Damico-Beyer LA, Joshi A. Pharmacokinetics of ranibizumab in patients with neovascular age-related macular degeneration: a population approach. Invest Ophthalmol Vis Sci. 2013 Mar 5;54(3):1616-24. doi: 10.1167/iovs.12-10260.

    PubMed 23361508

  • Bressler NM, Chang TS, Varma R, Suner I, Lee P, Dolan CM, Ward J, Ianchulev T, Fine J. Driving ability reported by neovascular age-related macular degeneration patients after treatment with ranibizumab. Ophthalmology. 2013 Jan;120(1):160-8. doi: 10.1016/j.ophtha.2012.07.027. Epub 2012 Sep 23.

    PubMed 23009891

  • Elshout M, van der Reis MI, Webers CA, La Heij EC, Hendrikse F, Schouten JS. A new epidemiological aid in deciding whether to continue or stop a treatment. Invest Ophthalmol Vis Sci. 2012 Jul 1;53(8):4331-6. doi: 10.1167/iovs.11-9242.

    PubMed 22661474

  • Rosenfeld PJ, Shapiro H, Ehrlich JS, Wong P; MARINA and ANCHOR Study Groups. Cataract surgery in ranibizumab-treated patients with neovascular age-related macular degeneration from the phase 3 ANCHOR and MARINA trials. Am J Ophthalmol. 2011 Nov;152(5):793-8. doi: 10.1016/j.ajo.2011.04.025. Epub 2011 Jul 26.

    PubMed 21794843

  • Hawkins BS, Bressler NM, Reynolds SM. Patient-reported outcomes among sham vs no-treatment controls from randomized trials. Arch Ophthalmol. 2011 Feb;129(2):200-5. doi: 10.1001/archophthalmol.2010.359.

    PubMed 21320967

  • Rosenfeld PJ, Shapiro H, Tuomi L, Webster M, Elledge J, Blodi B; MARINA and ANCHOR Study Groups. Characteristics of patients losing vision after 2 years of monthly dosing in the phase III ranibizumab clinical trials. Ophthalmology. 2011 Mar;118(3):523-30. doi: 10.1016/j.ophtha.2010.07.011.

    PubMed 20920825

  • Barbazetto I, Saroj N, Shapiro H, Wong P, Freund KB. Dosing regimen and the frequency of macular hemorrhages in neovascular age-related macular degeneration treated with ranibizumab. Retina. 2010 Oct;30(9):1376-85. doi: 10.1097/IAE.0b013e3181dcfb0b.

    PubMed 20683380

  • Barbazetto IA, Saroj N, Shapiro H, Wong P, Ho AC, Freund KB. Incidence of new choroidal neovascularization in fellow eyes of patients treated in the MARINA and ANCHOR trials. Am J Ophthalmol. 2010 Jun;149(6):939-946.e1. doi: 10.1016/j.ajo.2010.01.007. Epub 2010 Apr 8.

    PubMed 20378094

  • Bressler NM, Chang TS, Suner IJ, Fine JT, Dolan CM, Ward J, Ianchulev T; MARINA and ANCHOR Research Groups. Vision-related function after ranibizumab treatment by better- or worse-seeing eye: clinical trial results from MARINA and ANCHOR. Ophthalmology. 2010 Apr;117(4):747-56.e4. doi: 10.1016/j.ophtha.2009.09.002. Epub 2010 Mar 2.

    PubMed 20189654

  • Chang TS, Bressler NM, Fine JT, Dolan CM, Ward J, Klesert TR; MARINA Study Group. Improved vision-related function after ranibizumab treatment of neovascular age-related macular degeneration: results of a randomized clinical trial. Arch Ophthalmol. 2007 Nov;125(11):1460-9. doi: 10.1001/archopht.125.11.1460.

    PubMed 17998507

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing rhuFab V2 (ranibizumab) in people with Macular Degeneration, run by Genentech, Inc..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 May 2014. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00056836, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2014.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in