Macular EdemaNCT01442064

An Extension Study to Evaluate Safety and Tolerability of Ranibizumab in Macular Edema Secondary to Retinal Vein Occlusion (Cohort 2)

A study testing Ranibizumab 0.5 mg in people with Macular Edema and Retinal Vein Occlusion, 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 18 years and older
Conditions the study is for: Macular Edema, Retinal Vein Occlusion
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: 608 participants
Where: No sites listed yet
Study dates: Jul 2008to Jul 2010
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Signed informed consent form
The 6-month treatment and 6-month observation phases (12 months total) of a Genentech-sponsored ranibizumab study for RVO (FVF4165g or FVF4166g)
Expectation by the investigator that the subject may potentially benefit from intravitreal anti-vascular endothelial growth factor (VEGF) treatment

Who cannot join

History of intraocular surgery (including cataract extraction, scleral buckle, etc.) within 1 month prior to Day 0 of this extension study
Concurrent use of systemic anti-VEGF agents
Use of RVO treatments not approved by the Food and Drug Administration (FDA) in the study eye
Use of intravitreal bevacizumab in the study eye and/or fellow eye
Macular edema in the study eye due to other causes than RVO such as diabetes
History of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the study eye

Show all 13Show fewer

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 is an open-label, multicenter, extension study of intravitreally administered ranibizumab in two cohorts. The first cohort (reported separately under FVF3426g, NCT00379795) enrolled subjects 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 (reported here) enrolled subjects 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)). Patients were enrolled within 14 days of completion of the previous study.

Conditions: Macular Edema, Retinal Vein Occlusion
Being tested: Ranibizumab 0.5 mg
Keywords: CNV, Lucentis, AMD, Age-related macular degeneration, RVO, Macular edema secondary to retinal vein occlusion
Medical subject headings: Macular Edema, Retinal Vein Occlusion, 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
Also called Lucentis
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 NCT01442064
Study group	Role	What they receive
Ranibizumab 0.5 mg	Experimental	Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) for 24 months. 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 in the Study Eye
Number of participants with: any ocular adverse events, ocular adverse events causing treatment discontinuation, ocular serious adverse events, intraocular inflammation and cataracts that occurred in the study 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: Up to 24 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: Up to 24 months

Secondary outcomes (3)

Change From Baseline in the Best Corrected Visual Acuity (BCVA)
Change from baseline in then 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: Baseline (Day 0 of extension study), Months 6, 12, 18, and 24
Change From Baseline in Central Foveal Thickness at Month 6 and Month 12
Change from baseline in Central foveal (retinal) thickness was assessed by Optical Coherence Tomography (OCT). OCT was conducted at the study sites by personnel who were certified by the University of Wisconsin Fundus Photograph Reading Center.
Measured: Baseline (Day 0 of extension study), Months 6 and 12
Change From Baseline in Visual Function Composite Score, as Measured by the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25)
NEI VFQ-25 is a 25 item questionnaire that assesses visual function and quality of life for a total possible score of 0 to 100. A higher score represents better functioning. The change from baseline is calculated at Month 12 and Month 24.
Participants are grouped according to the treatment they received in initial studies FVF4165g BRAVO (NCT00486018) and FVF4166g CRUISE (NCT00485836).
Measured: Baseline (Day 0 of extension study), 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.

Jul 2008Jul 2010

First posted28 Sep 2011 (estimated)
Study startJul 2008
Primary completionJul 2010
Study completionJul 2010

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 Macular EdemaStudies 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: 608 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01442064
Sponsor's protocol ID: FVF3426g (Cohort 2)
Status last verified: Dec 2011
First submitted: 26 Sep 2011
Last updated: 10 Jan 2012
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

Active, not recruitingObservational study
Real World Evidence in China: Faricimab Use in Diabetic Macular Edema, Retinal Vein Occlusion, and Neovascular Age-Related Macular Degeneration (The Farseeing Study)
Diabetic Macular Edema, Neovascular Age-related Macular Degeneration
Not yet recruitingObservational study
Efficacy of Aflibercept (8 mg) With Sequential Laser Photocoagulation for Macular Edema Secondary to Retinal Artery Macroaneurysm: Retrospective Study"
Retinal Arterial Macroaneurysm
Active, not recruitingPhase 2
Long-Term Follow-Up Study of RGX-314 Administered in the Suprachoroidal Space for Participants With and Without Diabetic Retinopathy
Diabetic Retinopathy, DR
RecruitingPhase 3
A Phase 3 Trial for Intravitreal Injection of 4D-150 in Adults With Diabetic Macular Edema (DME).
Diabetic Macular Edema (DME)
RecruitingPhase 2
Oral N-Acetylcysteine on Diabetic Macular Edema
Diabetic Macular Edema (DME)

All Macular Edema trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Jan 2012. 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: NCT01442064
Acronym / sponsor ID: FVF3426g (Cohort 2)
Conditions: Macular Edema, Retinal Vein Occlusion
Keywords: CNV, Lucentis, AMD, Age-related macular degeneration, RVO, Macular edema secondary to retinal vein occlusion
Study type: Interventional
Recruitment status: Completed
Enrolment: 608 participants (actual)
Lead sponsor: Genentech, Inc.Industry (pharma, biotech, devices)
Study start: Jul 2008
Primary completion: Jul 2010 (actual)
Study completion: Jul 2010 (actual)
First posted: 28 Sep 2011 (estimated)
Results: Posted 10 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
Ranibizumab 0.5 mg	Experimental	Drug: Ranibizumab 0.5 mgRanibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) for 24 months.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Signed informed consent form
The 6-month treatment and 6-month observation phases (12 months total) of a Genentech-sponsored ranibizumab study for RVO (FVF4165g or FVF4166g)
Expectation by the investigator that the subject may potentially benefit from intravitreal anti-vascular endothelial growth factor (VEGF) treatment

Key exclusion criteria (13 listed)

History of intraocular surgery (including cataract extraction, scleral buckle, etc.) within 1 month prior to Day 0 of this extension study
Concurrent use of systemic anti-VEGF agents
Use of RVO treatments not approved by the Food and Drug Administration (FDA) in the study eye
Use of intravitreal bevacizumab in the study eye and/or fellow eye
Macular edema in the study eye due to other causes than RVO such as diabetes

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 mgAlso: LucentisRanibizumab 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	Ranibizumab 0.5 mg

Primary outcome

Number of Participants With Ocular Adverse Events in the Study Eye
Time frame: Up to 24 months
Number of participants with: any ocular adverse events, ocular adverse events causing treatment discontinuation, ocular serious adverse events, intraocular inflammation and cataracts that occurred in the study 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: Up to 24 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.

3 secondary outcomes

Change From Baseline in the Best Corrected Visual Acuity (BCVA)
Time frame: Baseline (Day 0 of extension study), Months 6, 12, 18, and 24
Change From Baseline in Central Foveal Thickness at Month 6 and Month 12
Time frame: Baseline (Day 0 of extension study), Months 6 and 12
Change From Baseline in Visual Function Composite Score, as Measured by the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25)
Time frame: Baseline (Day 0 of extension study), Months 12 and 24

Results and safety

Results posted to the registry on 10 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
Ranibizumab (Sham BRAVO)	97	0
Ranibizumab (0.3 mg BRAVO)	103	2
Ranibizumab (0.5 mg BRAVO)	104	0
Ranibizumab (Sham CRUISE)	98	0
Ranibizumab (0.3 mg CRUISE)	107	1
Ranibizumab (0.5 mg CRUISE)	99	0

Primary outcome: Number of Participants With Ocular Adverse Events in the Study Eye

Time frame: Up to 24 months. Number. Unit: participants

Measure	Ranibizumab (Sham BRAVO) n = 93	Ranibizumab (0.3 mg BRAVO) n = 103	Ranibizumab (0.5 mg BRAVO) n = 104	Ranibizumab (Sham CRUISE) n = 96	Ranibizumab (0.3 mg CRUISE) n = 107	Ranibizumab (0.5 mg CRUISE) n = 99
Any ocular adverse event (AE)	51	64	63	60	67	66
Ocular AE leading to treatment discontinuation	1	2	2	0	2	2
Ocular serious adverse event	2	4	6	5	10	3
Intraocular inflammation	0	0	0	2	3	1
Cataract	6	10	6	3	6	5

Population analysed: Ranibizumab- Treated Participants includes all participants who received Ranibizumab in one of the initial studies or this extension study. This analysis includes only those adverse events that occurred during this extension study.

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

Time frame: Up to 24 months. Number. Unit: participants

Measure	Ranibizumab (Sham BRAVO) n = 93	Ranibizumab (0.3 mg BRAVO) n = 103	Ranibizumab (0.5 mg BRAVO) n = 104	Ranibizumab (Sham CRUISE) n = 96	Ranibizumab (0.3 mg CRUISE) n = 107	Ranibizumab (0.5 mg CRUISE) n = 99
Any non-ocular adverse event	56	77	68	58	71	64
Serious non-ocular adverse event	10	15	18	16	21	20
Non-ocular adverse event led to discontinuation	1	0	1	0	1	0
Death	0	1	3	3	1	3

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 24 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ranibizumab (Sham)	32 of 189 (16.9%)	146 of 189 (77.2%)	Not reported
Ranibizumab (0.3 mg)	49 of 210 (23.3%)	179 of 210 (85.2%)	Not reported
Ranibizumab (0.5 mg)	46 of 203 (22.7%)	172 of 203 (84.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Macular Edema

Active, not recruitingObservational study
Real World Evidence in China: Faricimab Use in Diabetic Macular Edema, Retinal Vein Occlusion, and Neovascular Age-Related Macular Degeneration (The Farseeing Study)
Diabetic Macular Edema, Neovascular Age-related Macular Degeneration
Not yet recruitingObservational study
Efficacy of Aflibercept (8 mg) With Sequential Laser Photocoagulation for Macular Edema Secondary to Retinal Artery Macroaneurysm: Retrospective Study"
Retinal Arterial Macroaneurysm
Active, not recruitingPhase 2
Long-Term Follow-Up Study of RGX-314 Administered in the Suprachoroidal Space for Participants With and Without Diabetic Retinopathy
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RecruitingPhase 3
A Phase 3 Trial for Intravitreal Injection of 4D-150 in Adults With Diabetic Macular Edema (DME).
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RecruitingPhase 2
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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.

Phillip Lai, 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 Macular Edema and Retinal Vein Occlusion, 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 13 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 10 Jan 2012. 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 10 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 in the Study Eye (time frame: Up to 24 months). The study lists 2 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 NCT01442064.

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 10 Jan 2012.