Choroidal Neovascularization, Age-related Macular DegenerationNCT00379795

An Extension Study to Evaluate the Safety and Tolerability of Ranibizumab in Subjects With Choroidal Neovascularization Secondary to AMD or Macular Edema Secondary to RVO

A study testing Ranibizumab 0.5 mg in people with Choroidal Neovascularization, Age-related 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

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Trial summary

Who is it for?: Ages 50 years and older
Conditions the study is for: Choroidal Neovascularization, Age-related Macular Degeneration
What is being tested?: Ranibizumab 0.5 mg
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 853 participants
Where: No sites listed yet
Study dates: Apr 2005to Sep 2008
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 form.
Completion of the treatment phase (through Month 24) of a Genentech-sponsored ranibizumab study for AMD (FVF2598g, FVF2587g, or FVF2428g) (Cohort 1)
Expectation by the investigator that the subject may potentially benefit from intravitreal anti-vascular endothelial growth factor (VEGF) treatment

Who cannot join

Previous subfoveal focal laser photocoagulation in the study eye
Previous pegaptanib sodium injection in the study eye
Laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within 1 month preceding Day 0 of this extension study
History of submacular surgery or other surgical intervention for AMD in the study eye
History of glaucoma filtering surgery in the study eye
History of corneal transplant in the study eye

Show all 18Show fewer

Concurrent use of systemic anti-EGF agents
Use of AMD treatments not approved by the FDA
Use of intravitreal Avastin(R) (bevacizumab) in the study eye and/or fellow eye
CNV in either eye due to other causes than AMD, such as ocular histoplasmosis, trauma, or pathologic myopia for Cohort 1
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
Uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥ 30 mmHg despite treatment with antiglaucoma medication)
Pregnancy or lactation
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 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
Inability to comply with study or follow-up procedures

About this study

Official title: An Open-Label, Multicenter Extension Study to Evaluate the Safety and Tolerability of Ranibizumab in Subjects With Choroidal Neovascularization (CNV) Secondary to Age-Related Macular Degeneration (AMD) or Macular Edema Secondary to Retinal Vein Occlusion (RVO) Who Have Completed a Genentech-Sponsored Ranibizumab Study

This was an open-label, multicenter, extension study of intravitreally administered ranibizumab in two cohorts. The first cohort (reported here) enrolled patients with primary or recurrent Choroidal Neovascularization (CNV) secondary to Age-Related Macular Degeneration (AMD) who completed the treatment phase of a Genentech sponsored study (FVF2598g (NCT00056836), FVF2587g (NCT00061594), or FVF2428g (NCT00056823)). The second cohort enrolled patients with macular edema secondary to Retinal Vein Occlusion (RVO) who completed the 6-month treatment and 6-month observation phases (12 months total) of a Genentech sponsored study (FVF4165g (NCT00486018) or FVF4166g (NCT00485836)). The results of the second cohort are reported separately (NCT01442064). The first cohort of this study enrolled two subsets of patients: ranibizumab experienced and ranibizumab-naive. Patients were enrolled within 14 days of completion of the 24 month treatment phase of the previous study.

Conditions: Choroidal Neovascularization, Age-related Macular Degeneration
Being tested: Ranibizumab 0.5 mg
Keywords: CNV, Lucentis, AMD, Age-related macular degeneration, RVO
Medical subject headings: Choroidal Neovascularization, Macular Degeneration

What participants receive

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

Ranibizumab 0.5 mgDrug
Ranibizumab intravitreal injection 0.5 mg in a single-dose regimen given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year)

Study groups in NCT00379795
Study group	Role	What they receive
Ranibizumad 0.5 mg	Experimental	Ranibizumab 0.5 mg intravitreal injection 0.5 mg in the study eye on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Receives: Drug: Ranibizumab 0.5 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Ocular Adverse Events
Number of participants with ocular adverse events in the following categories: any adverse events, serious adverse events, adverse events leading to study discontinuation, endophthalmitis and intraocular inflammation that occurred in the study eye (the eye that received all study drug injections) and the fellow eye (other eye).
Only adverse events that occurred during this extension study are reported. For subjects in the crossover groups who started their first ranibizumab injection in this extension study, adverse events that occurred prior to any ranibizumab injection were also excluded.
Measured: 36 months
Number of Participants With Non-ocular Adverse Events
Number of participants with non-ocular adverse events (not occurring in the eye) in the following categories: any adverse events, serious adverse events, adverse events leading to study discontinuation and death.
Only adverse events that occurred during this extension study are reported. For subjects in the crossover groups who started their first ranibizumab injection in this extension study, adverse events that occurred prior to any ranibizumab injection were also excluded.
Additional information about adverse events can be found in the adverse events section.
Measured: 36 months
Number of Participants With Positive Serum Antibodies to Ranibizumab at Month 12 and Month 24
Serum samples for the evaluation of antibodies to Ranibizumab were collected at Month 12 and Month 24 and were sent to a reference laboratory for analysis. If an injection of Ranibizumab was required at the visit, the samples were collected prior to the injection.
Measured: Month 12 and 24

Secondary outcomes (2)

Change From Baseline in Best Corrected Visual Acuity (BCVA) at a Starting Test Distance of 2 Meters
Change from baseline in Best corrected visual acuity (BCVA) was assessed by the number of letters a patient could read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) Eye Chart at a starting test distance of 2 meters. An increase in the number of letters read indicates improvement in visual acuity.
Measured: Extension study baseline, Months 3, 6, 9, 12, 15, 18, 21 and 24
Change From Baseline in Best Corrected Visual Acuity at a Starting Test Distance of 4 Meters
Change from baseline in Best corrected visual acuity (BCVA) was assessed by the number of letters a patient could read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) Eye Chart at a starting test distance of 4 meters. An increase in the number of letters read indicates improvement in visual acuity.
Measured: Extension study baseline, Months 12 and 24

Timeline

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

Apr 2005Sep 2008

First posted22 Sep 2006 (estimated)
Study startApr 2005
Primary completionSep 2008
Study completionSep 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Choroidal Neovascularization, Age-related Macular DegenerationStudies of the same condition, open and under way.
More trials run by Genentech, Inc.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 853 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00379795
Sponsor's protocol ID: FVF3426g (Cohort 1)
Status last verified: Apr 2017
First submitted: 21 Sep 2006
Last updated: 11 May 2017
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Not yet recruitingPhase 2
A Study to Evaluate the Efficacy and Safety of VIS-101 in Participants With Neovascular Age-Related Macular Degeneration
Neovascular Age Related Macular Degeneration(nAMD)
Active, not recruitingPhase 2
Safety and Efficacy of ADVM-022 in Treatment-Experienced Patients With Neovascular Age-related Macular Degeneration [LUNA]
Neovascular Age-related Macular Degeneration
RecruitingPhase 2/3
A Clinical Trial of EYE201/MK-8748 in People With Macular Degeneration (MK-8748-002)
Macular Degeneration, Age-Related Macular Degeneration
Active, not recruiting
Speculum-Free Intravitreal Injection Using Cotton-Tipped Applicator Retraction: Pain, Procedure Time, Patient Satisfaction, and Safety
Neovascular Age-Related Macular Degeneration (nAMD), Diabetic Macular Edema
Active, not recruitingPhase 1/2
NG101 AAV Gene Therapy in Subjects With Wet Age-Related Macular Degeneration
Age-Related Macular Degeneration

All Choroidal Neovascularization, Age-related Macular Degeneration trials

Study at a glance

From the registry record, last updated by the sponsor on 11 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label, Multicenter Extension Study to Evaluate the Safety and Tolerability of Ranibizumab in Subjects With Choroidal Neovascularization (CNV) Secondary to Age-Related Macular Degeneration (AMD) or Macular Edema Secondary to Retinal Vein Occlusion (RVO) Who Have Completed a Genentech-Sponsored Ranibizumab Study
ClinicalTrials.gov ID: NCT00379795
Acronym / sponsor ID: FVF3426g (Cohort 1)
Conditions: Choroidal Neovascularization, Age-related Macular Degeneration
Keywords: CNV, Lucentis, AMD, Age-related macular degeneration, RVO
Study type: Interventional
Recruitment status: Completed
Enrolment: 853 participants (actual)
Lead sponsor: Genentech, Inc.Industry (pharma, biotech, devices)
Study start: Apr 2005
Primary completion: Sep 2008 (actual)
Study completion: Sep 2008 (actual)
First posted: 22 Sep 2006 (estimated)
Results: Posted 13 Jan 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Ranibizumad 0.5 mg	Experimental	Drug: Ranibizumab 0.5 mgRanibizumab 0.5 mg intravitreal injection 0.5 mg in the study eye on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment.

Who may qualify

Ages: 50 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Signed informed consent form.
Completion of the treatment phase (through Month 24) of a Genentech-sponsored ranibizumab study for AMD (FVF2598g, FVF2587g, or FVF2428g) (Cohort 1)
Expectation by the investigator that the subject may potentially benefit from intravitreal anti-vascular endothelial growth factor (VEGF) treatment

Key exclusion criteria (18 listed)

Previous subfoveal focal laser photocoagulation in the study eye
Previous pegaptanib sodium injection in the study eye
Laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within 1 month preceding Day 0 of this extension study
History of submacular surgery or other surgical intervention for AMD in the study eye
History of glaucoma filtering surgery in the study eye

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Ranibizumab 0.5 mgRanibizumab intravitreal injection 0.5 mg in a single-dose regimen given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year)	Drug	Ranibizumad 0.5 mg

Primary outcome

Number of Participants With Ocular Adverse Events
Time frame: 36 months
Number of participants with ocular adverse events in the following categories: any adverse events, serious adverse events, adverse events leading to study discontinuation, endophthalmitis and intraocular inflammation that occurred in the study eye (the eye that received all study drug injections) and the fellow eye (other eye). Only adverse events that occurred during this extension study are reported. For subjects in the crossover groups who started their first ranibizumab injection in this extension study, adverse events that occurred prior to any ranibizumab injection were also excluded.
Number of Participants With Non-ocular Adverse Events
Time frame: 36 months
Number of participants with non-ocular adverse events (not occurring in the eye) in the following categories: any adverse events, serious adverse events, adverse events leading to study discontinuation and death. Only adverse events that occurred during this extension study are reported. For subjects in the crossover groups who started their first ranibizumab injection in this extension study, adverse events that occurred prior to any ranibizumab injection were also excluded. Additional information about adverse events can be found in the adverse events section.
Number of Participants With Positive Serum Antibodies to Ranibizumab at Month 12 and Month 24
Time frame: Month 12 and 24
Serum samples for the evaluation of antibodies to Ranibizumab were collected at Month 12 and Month 24 and were sent to a reference laboratory for analysis. If an injection of Ranibizumab was required at the visit, the samples were collected prior to the injection.

2 secondary outcomes

Change From Baseline in Best Corrected Visual Acuity (BCVA) at a Starting Test Distance of 2 Meters
Time frame: Extension study baseline, Months 3, 6, 9, 12, 15, 18, 21 and 24
Change From Baseline in Best Corrected Visual Acuity at a Starting Test Distance of 4 Meters
Time frame: Extension study baseline, Months 12 and 24

Results and safety

Results posted to the registry on 13 Jan 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
RanibizumabTreated Initial Mono	526	50
RanibizumabTreated Initial + PDT	74	23
RanibizumabTreated Sham XO	116	23
Ranibizumab Treated PDT XO	74	6
Ranibizumab Untreated Group	63	14

Primary outcome: Number of Participants With Ocular Adverse Events

Time frame: 36 months. Number. Unit: participants

Measure	Ranibizumab Treated Initial Mono n = 526	Ranibizumab Treated Initial + PDT n = 74	Ranibizumab Treated Sham XO n = 116	Ranibizumab Treated PDT XO n = 74
Any adverse event in study eye	418	56	96	59
Serious adverse events in study eye	46	2	6	2
Adverse events led to discontinuation, study eye	7	2	3	2
Endophthalmitis in study eye	1	0	0	0
Intraocular inflammation in study eye, total	8	2	4	1
Serious Intraocular inflammation in study eye	1	0	0	0
Any adverse event in fellow eye	304	50	72	47
Serious adverse events in fellow eye	22	4	6	3

Population analysed: All enrolled participants treated with Ranibizumab in this extension study or in one of the previous studies.

Primary outcome: Number of Participants With Non-ocular Adverse Events

Time frame: 36 months. Number. Unit: participants

Measure	Ranibizumab Treated Initial Mono n = 526	Ranibizumab Treated Initial + PDT n = 74	Ranibizumab Treated Sham XO n = 116	Ranibizumab Treated PDT XO n = 74
Any non ocular adverse event	427	61	92	58
Serious non ocular adverse event	169	21	33	20
Non ocular adverse events led to discontinuation	27	2	1	0
Death	31	8	6	4

Population analysed: Enrolled participants treated with Ranibizumab in this extension study or in one of the previous studies.

Primary outcome: Number of Participants With Positive Serum Antibodies to Ranibizumab at Month 12 and Month 24

Time frame: Month 12 and 24. Number. Unit: participants

Measure	Ranibizumab Treated Initial Mono n = 526	Ranibizumab Treated Initial + PDT n = 74	Ranibizumab Treated Sham XO n = 116	Ranibizumab Treated PDT XO n = 74
Month 12 (n=393,55,72,50)	10	0	1	0
Month 24 (n=316,45,78,42)	9	0	1	0

Population analysed: Population included all enrolled participants treated with Ranibizumab in the extension study or in one of the initial studies. The number of participants for whom data was available at Month 12 and Month 24 are represented by "n"

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: The summary includes adverse events that occurred from enrollment in this extension study through 36 months (+/- 7 days).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ranibizumab Treated Initial Mono	213 of 526 (40.5%)	491 of 526 (93.3%)	Not reported
Ranibizumab Treated Initial + PDT	26 of 74 (35.1%)	70 of 74 (94.6%)	Not reported
Ranibizumab Treated Sham XO	43 of 116 (37.1%)	110 of 116 (94.8%)	Not reported
Ranibizumab Treated PDT XO	24 of 74 (32.4%)	71 of 74 (95.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Choroidal Neovascularization, Age-related Macular Degeneration

Not yet recruitingPhase 2
A Study to Evaluate the Efficacy and Safety of VIS-101 in Participants With Neovascular Age-Related Macular Degeneration
Neovascular Age Related Macular Degeneration(nAMD)
Active, not recruitingPhase 2
Safety and Efficacy of ADVM-022 in Treatment-Experienced Patients With Neovascular Age-related Macular Degeneration [LUNA]
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Lisa Tuomi, M.D. study director

Genentech, Inc.

Questions about this trial

What is this clinical trial studying?

A study testing Ranibizumab 0.5 mg in people with Choroidal Neovascularization, Age-related 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 3 inclusion and 18 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 11 May 2017. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Jan 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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.

What does the primary outcome measure?

Number of Participants With Ocular Adverse Events (time frame: 36 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00379795.

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 11 May 2017.