Trial · NCT00379795

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

NCT00379795, Not applicable, Completed, Genentech, Inc.; results first posted 2012-01-13

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. 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. Trials, record NCT00379795. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00379795

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: 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
NCT number: NCT00379795
Status: Completed
Phases: Not applicable
Enrollment: 853 participants, actual
Lead sponsor: Genentech, Inc.
Conditions: Choroidal Neovascularization, Age-related Macular Degeneration
Interventions: Ranibizumab 0.5 mg
First posted: 2006-09-22
Last updated: 2017-05-11
Results first posted: 2012-01-13

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Participants With Ocular Adverse Events	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.
Primary	Number of Participants With Non-ocular Adverse Events	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.
Primary	Number of Participants With Positive Serum Antibodies to Ranibizumab at Month 12 and Month 24	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.
Secondary	Change From Baseline in Best Corrected Visual Acuity (BCVA) at a Starting Test Distance of 2 Meters	Extension study baseline, Months 3, 6, 9, 12, 15, 18, 21 and 24	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.
Secondary	Change From Baseline in Best Corrected Visual Acuity at a Starting Test Distance of 4 Meters	Extension study baseline, Months 12 and 24	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.

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Participants With Ocular Adverse Events	36 months	All enrolled participants treated with Ranibizumab in this extension study or in one of the previous studies.	participants	NUMBER
PRIMARY	Number of Participants With Non-ocular Adverse Events	36 months	Enrolled participants treated with Ranibizumab in this extension study or in one of the previous studies.	participants	NUMBER
SECONDARY	Change From Baseline in Best Corrected Visual Acuity (BCVA) at a Starting Test Distance of 2 Meters	Extension study baseline, Months 3, 6, 9, 12, 15, 18, 21 and 24	Enrolled participants. Observed data were used with no imputation. The number of participants for whom data was available for analyses is represented by n.	letters	MEAN
SECONDARY	Change From Baseline in Best Corrected Visual Acuity at a Starting Test Distance of 4 Meters	Extension study baseline, Months 12 and 24	Enrolled participants. Observed data were used with no imputation. The number of participants for whom data was available for analyses is represented by n.	letters	MEAN
PRIMARY	Number of Participants With Positive Serum Antibodies to Ranibizumab at Month 12 and Month 24	Month 12 and 24	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	participants	NUMBER

Source ClinicalTrials.gov

Results by group112

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Number of Participants With Ocular Adverse Events	Ranibizumab Treated Initial Mono	Any adverse event in study eye	418	participants
Number of Participants With Ocular Adverse Events	Ranibizumab Treated Initial + PDT	Any adverse event in study eye	56	participants
Number of Participants With Ocular Adverse Events	Ranibizumab Treated Sham XO	Any adverse event in study eye	96	participants
Number of Participants With Ocular Adverse Events	Ranibizumab Treated PDT XO	Any adverse event in study eye	59	participants
Number of Participants With Ocular Adverse Events	Ranibizumab Treated Initial Mono	Serious adverse events in study eye	46	participants
Number of Participants With Ocular Adverse Events	Ranibizumab Treated Initial + PDT	Serious adverse events in study eye	2	participants
Number of Participants With Ocular Adverse Events	Ranibizumab Treated Sham XO	Serious adverse events in study eye	6	participants
Number of Participants With Ocular Adverse Events	Ranibizumab Treated PDT XO	Serious adverse events in study eye	2	participants
Number of Participants With Ocular Adverse Events	Ranibizumab Treated Initial Mono	Adverse events led to discontinuation, study eye	7	participants
Number of Participants With Ocular Adverse Events	Ranibizumab Treated Initial + PDT	Adverse events led to discontinuation, study eye	2	participants

1 to 10 of 112Source ClinicalTrials.gov

See all 112 results by group

Participant flow20

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	RanibizumabTreated Initial Mono	526
Overall Study	STARTED	RanibizumabTreated Initial + PDT	74
Overall Study	STARTED	RanibizumabTreated Sham XO	116
Overall Study	STARTED	Ranibizumab Treated PDT XO	74
Overall Study	STARTED	Ranibizumab Untreated Group	63
Overall Study	Received Ranibizumab in Extension Study	RanibizumabTreated Initial Mono	377
Overall Study	Received Ranibizumab in Extension Study	RanibizumabTreated Initial + PDT	41
Overall Study	Received Ranibizumab in Extension Study	RanibizumabTreated Sham XO	113
Overall Study	Received Ranibizumab in Extension Study	Ranibizumab Treated PDT XO	55
Overall Study	Received Ranibizumab in Extension Study	Ranibizumab Untreated Group	0

1 to 10 of 20Source ClinicalTrials.gov

See all 20 participant flow

Adverse events1,012

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	ANAEMIA	Blood and lymphatic system disorders	Ranibizumab Treated Initial Mono	27	526
other	ANAEMIA	Blood and lymphatic system disorders	Ranibizumab Treated Initial + PDT	3	74
other	ANAEMIA	Blood and lymphatic system disorders	Ranibizumab Treated Sham XO	3	116
other	ANAEMIA	Blood and lymphatic system disorders	Ranibizumab Treated PDT XO	3	74
other	ATRIAL FIBRILLATION	Cardiac disorders	Ranibizumab Treated Initial Mono	14	526
other	ATRIAL FIBRILLATION	Cardiac disorders	Ranibizumab Treated Initial + PDT	4	74
other	ATRIAL FIBRILLATION	Cardiac disorders	Ranibizumab Treated Sham XO	3	116
other	ATRIAL FIBRILLATION	Cardiac disorders	Ranibizumab Treated PDT XO	0	74
other	MACULAR DEGENERATION	Eye disorders	Ranibizumab Treated Initial Mono	236	526
other	MACULAR DEGENERATION	Eye disorders	Ranibizumab Treated Initial + PDT	18	74

1 to 10 of 1,012Source ClinicalTrials.gov

See all 1,012 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Ranibizumab Treated Initial Mono
Total, all-cause mortality	Ranibizumab Treated Initial + PDT
Total, all-cause mortality	Ranibizumab Treated Sham XO
Total, all-cause mortality	Ranibizumab Treated PDT XO
Total, other adverse events	Ranibizumab Treated Initial Mono	491	526
Total, other adverse events	Ranibizumab Treated Initial + PDT	70	74
Total, other adverse events	Ranibizumab Treated Sham XO	110	116
Total, other adverse events	Ranibizumab Treated PDT XO	71	74
Total, serious adverse events	Ranibizumab Treated Initial Mono	213	526
Total, serious adverse events	Ranibizumab Treated Initial + PDT	26	74

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00379795

GET https://conductscience.org/api/trials/v1/NCT00379795/results?page=2

API reference For AI assistants