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 - Study Results

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Choroidal Neovascularization, Age-related Macular Degeneration
Intervention:	Drug: Ranibizumab 0.5 mg

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This is an open label multicenter extension study for participants who have completed one of the following studies: FVF2428g (NCT00056823), FVF2587g (NCT00061594) or FVF2598g (NCT0056823). Cohort 1 includes patients with Choroidal Neovascularization (CNV) Secondary to Age-Related Macular Degeneration (AMD).

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants were classified according to ranibizumab exposure in the previous study and in the extension study. 63 participants (Untreated Group) did not receive study drug in this extension study or in the previous studies and are not included in the safety analyses.

Reporting Groups

	Description
RanibizumabTreated Initial Mono	In this extension study participants received Ranibizumab 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. Participants in this group received ranibizumab monotherapy (Mono) in previous studies, that is, ranibizumab alone in study FVF2598g or ranibizumab in combination with sham photodynamic therapy (PDT) in study FVF2587g.
RanibizumabTreated Initial + PDT	In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given 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. This group includes participants who received ranibizumab in combination with photodynamic therapy in Study FVF2428g
RanibizumabTreated Sham XO	In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given 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. Ranibizumab Treated Sham Crossover (XO) includes participants who received sham intravitreal injections before crossing over to receive ranibizumab intravitreal injections in study FVF2598g or this extension study.
Ranibizumab Treated PDT XO	In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given 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. Ranibizumab Treated PDT XO includes participants who received sham intravitreal injections in combination with photodynamic therapy in study FVF2428g or study FVF2587g before crossing over to receive ranibizumab intravitreal injections in study FVF2428g, study FVF2587g or this study.
Ranibizumab Untreated Group	In this extension study participants did not receive Ranibizumab. Participants in this group were enrolled in one of the following studies: FVF2428g (NCT00056823), FVF2587g (NCT00061594) FVF2598g (NCT0056823) but did not receive Ranibizumab intravitreal injections in that study or in this extension study (FVF3426g).

Participant Flow: Overall Study

	RanibizumabTreated Initial Mono	RanibizumabTreated Initial + PDT	RanibizumabTreated Sham XO	Ranibizumab Treated PDT XO	Ranibizumab Untreated Group
STARTED	526	74	116	74	63
Received Ranibizumab in Extension Study	377	41	113	55	0
COMPLETED	50	23	23	6	14
NOT COMPLETED	476	51	93	68	49
Death	31	8	6	4	7
Adverse Event	17	3	3	1	4
Lost to Follow-up	8	1	2	1	4
Physician Decision	25	0	2	2	2
Withdrawal by Subject	94	11	19	7	14
Subject non-compliance	7	2	0	0	1
Verteporfin photodynamic therapy in eye	3	0	0	1	0
Subjects condition mandated intervention	34	9	7	5	7
Sponsor's decision	257	17	54	47	10

Baseline Characteristics

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Reporting Groups

	Description
RanibizumabTreated Initial Mono	In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given 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. Participants in this group received ranibizumab 0.5 mg monotherapy, that is, ranibizumab alone in study FVF2598g or ranibizumab in combination with sham photodynamic therapy (PDT) in study FVF2587g.
RanibizumabTreated Initial + PDT	In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given 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. This group includes participants who received ranibizumab 0.5 mg intravitreal injections in combination with photodynamic therapy in Study FVF2428g.
RanibizumabTreated Sham XO	In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given 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. Ranibizumab Treated Sham Crossover (XO) includes participants who received sham intravitreal injections before crossing over to receive ranibizumab 0.5mg intravitreal injections in previous study FVF2598g or in this extension study.
Ranibizumab Treated PDT XO	In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given 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. Ranibizumab Treated PDT XO includes participants who received sham intravitreal injections in combination with photodynamic therapy in study FVF2428g or study FVF2587g before crossing over to receive ranibizumab 0.5 mg intravitreal injections in previous studies FVF2428g, study FVF2587g or this extension study.
Ranibizumab Untreated Group	In this extension study participants did not receive Ranibizumab. Participants in this group were previously enrolled in one of the following studies: FVF2428g (NCT00056823), FVF2587g (NCT00061594), FVF2598g (NCT0056823) but did not receive treatment with Ranibizumab in that study or in this extension study (FVF3426g).
Total	Total of all reporting groups

Baseline Measures

	RanibizumabTreated Initial Mono	RanibizumabTreated Initial + PDT	RanibizumabTreated Sham XO	Ranibizumab Treated PDT XO	Ranibizumab Untreated Group	Total
Number of Participants [units: participants]	526	74	116	74	63	853
Age, Customized [units: participants]
50 to < 65	29	5	5	8	4	51
65 to < 75	117	19	27	21	10	194
75 to < 85	277	42	61	35	29	444
>= 85	103	8	23	10	20	164
Gender [units: participants]
Female	304	42	76	41	36	499
Male	222	32	40	33	27	354

Outcome Measures

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1. Primary:

Number of Participants With Ocular Adverse Events [ Time Frame: 36 months ]

Measure Type	Primary
Measure Title	Number of Participants With Ocular Adverse Events
Measure Description	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.
Time Frame	36 months
Safety Issue	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All enrolled participants treated with Ranibizumab in this extension study or in one of the previous studies.

Reporting Groups

	Description
Ranibizumab Treated Initial Mono	In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given 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. Participants in this group previously received ranibizumab monotherapy (Mono), that is, ranibizumab 0.5 mg intravitreal injection alone in previous study FVF2598g or ranibizumab 0.5 mg intravitreal injection in combination with sham photodynamic therapy (PDT) in previous study FVF2587g.
Ranibizumab Treated Initial + PDT	In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given 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. This group includes participants who received ranibizumab 0.5 mg intravitreal injection in combination with photodynamic therapy in previous Study FVF2428g.
Ranibizumab Treated Sham XO	In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given 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. Ranibizumab Treated Sham Crossover (XO) includes participants who received sham intravitreal injections before crossing over to receive ranibizumab 0.5 mg intravitreal injection in previous study FVF2598g or this extension study.
Ranibizumab Treated PDT XO	In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given 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. Ranibizumab Treated PDT XO includes participants who received sham intravitreal injections in combination with photodynamic therapy in previous study FVF2428g or previous study FVF2587g before crossing over to receive ranibizumab 0.5 mg intravitreal injection in previous study FVF2428g, previous study FVF2587g or this extension study.

Measured Values

	Ranibizumab Treated Initial Mono	Ranibizumab Treated Initial + PDT	Ranibizumab Treated Sham XO	Ranibizumab Treated PDT XO
Number of Participants Analyzed [units: participants]	526	74	116	74
Number of Participants With Ocular Adverse Events [units: participants]
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
Adverse events led to discontinuation, fellow eye	6	7	4	3
Endophthalmitis in fellow eye	0	0	0	0
Intraocular inflammation in fellow eye, total	5	0	0	0
Serious intraocular inflammation in fellow eye	1	0	0	0

No statistical analysis provided for Number of Participants With Ocular Adverse Events

2. Primary:

Number of Participants With Non-ocular Adverse Events [ Time Frame: 36 months ]

Measure Type	Primary
Measure Title	Number of Participants With Non-ocular Adverse Events
Measure Description	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.
Time Frame	36 months
Safety Issue	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Enrolled participants treated with Ranibizumab in this extension study or in one of the previous studies.

Reporting Groups

	Description
Ranibizumab Treated Initial Mono	In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given 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. Participants in this group previously received ranibizumab monotherapy (Mono), that is, ranibizumab 0.5 mg intravitreal injection alone in previous study FVF2598g or ranibizumab 0.5 mg intravitreal injection in combination with sham photodynamic therapy (PDT) in previous study FVF2587g.
Ranibizumab Treated Initial + PDT	In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given 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. This group includes participants who received ranibizumab 0.5 mg intravitreal injection in combination with photodynamic therapy in previous Study FVF2428g.
Ranibizumab Treated Sham XO	In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given 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. Ranibizumab Treated Sham Crossover (XO) includes participants who received sham intravitreal injections before crossing over to receive ranibizumab 0.5 mg intravitreal injection in previous study FVF2598g or this extension study.
Ranibizumab Treated PDT XO	In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given 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. Ranibizumab Treated PDT XO includes participants who received sham intravitreal injections in combination with photodynamic therapy in previous study FVF2428g or previous study FVF2587g before crossing over to receive ranibizumab 0.5 mg intravitreal injection in previous study FVF2428g, previous study FVF2587g or this extension study.

Measured Values

	Ranibizumab Treated Initial Mono	Ranibizumab Treated Initial + PDT	Ranibizumab Treated Sham XO	Ranibizumab Treated PDT XO
Number of Participants Analyzed [units: participants]	526	74	116	74
Number of Participants With Non-ocular Adverse Events [units: participants]
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

No statistical analysis provided for Number of Participants With Non-ocular Adverse Events

3. Primary:

Number of Participants With Positive Serum Antibodies to Ranibizumab at Month 12 and Month 24 [ Time Frame: Month 12 and 24 ]

Measure Type	Primary
Measure Title	Number of Participants With Positive Serum Antibodies to Ranibizumab at Month 12 and Month 24
Measure Description	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.
Time Frame	Month 12 and 24
Safety Issue	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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"

Reporting Groups

	Description
Ranibizumab Treated Initial Mono	In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given 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. Participants in this group previously received ranibizumab monotherapy (Mono), that is, ranibizumab 0.5 mg intravitreal injection alone in previous study FVF2598g or ranibizumab 0.5 mg intravitreal injection in combination with sham photodynamic therapy (PDT) in previous study FVF2587g.
Ranibizumab Treated Initial + PDT	In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given 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. This group includes participants who received ranibizumab 0.5 mg intravitreal injection in combination with photodynamic therapy in previous Study FVF2428g.
Ranibizumab Treated Sham XO	In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given 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. Ranibizumab Treated Sham Crossover (XO) includes participants who received sham intravitreal injections before crossing over to receive ranibizumab 0.5 mg intravitreal injection in previous study FVF2598g or this extension study.
Ranibizumab Treated PDT XO	In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given 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. Ranibizumab Treated PDT XO includes participants who received sham intravitreal injections in combination with photodynamic therapy in previous study FVF2428g or previous study FVF2587g before crossing over to receive ranibizumab 0.5 mg intravitreal injection in previous study FVF2428g, previous study FVF2587g or this extension study.

Measured Values

	Ranibizumab Treated Initial Mono	Ranibizumab Treated Initial + PDT	Ranibizumab Treated Sham XO	Ranibizumab Treated PDT XO
Number of Participants Analyzed [units: participants]	526	74	116	74
Number of Participants With Positive Serum Antibodies to Ranibizumab at Month 12 and Month 24 [units: participants]
Month 12 (n=393,55,72,50)	10	0	1	0
Month 24 (n=316,45,78,42)	9	0	1	0

No statistical analysis provided for Number of Participants With Positive Serum Antibodies to Ranibizumab at Month 12 and Month 24

4. Secondary:

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 ]

Measure Type	Secondary
Measure Title	Change From Baseline in Best Corrected Visual Acuity (BCVA) at a Starting Test Distance of 2 Meters
Measure Description	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.
Time Frame	Extension study baseline, Months 3, 6, 9, 12, 15, 18, 21 and 24
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Enrolled participants. Observed data were used with no imputation. The number of participants for whom data was available for analyses is represented by "n".

Reporting Groups

	Description
Ranibizumab Initial Group	In this extension study participants received Ranibizumab 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) for 24 months. Participants in this group were initially enrolled and received treatment with Ranibizumab in one of the following studies: FVF2428g (NCT00056823), FVF2587g (NCT00061594) or FVF2598g (NCT0056823).
Ranibizumab Crossover Group	In this extension study participants received Ranibizumab 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) for 24 months. Participants in this group were enrolled but did not initially receive Ranibizumab in Study FVF2428g (NCT00056823), Study FVF2587g (NCT00061594) or Study FVF2598g (NCT00056836) and then crossed over to receive Ranibizumab either in that initial study or this extension study.
Ranibizumab Untreated Group	In this extension study participants did not receive Ranibizumab. Participants in this group were enrolled in one of the following studies: FVF2428g (NCT00056823), FVF2587g (NCT00061594) or FVF2598g (NCT0056823) but did not receive treatment with Ranibizumab in that study or this extension study.
Total	All enrolled subjects

Measured Values

	Ranibizumab Initial Group	Ranibizumab Crossover Group	Ranibizumab Untreated Group	Total
Number of Participants Analyzed [units: participants]	600	190	63	853
Change From Baseline in Best Corrected Visual Acuity (BCVA) at a Starting Test Distance of 2 Meters [units: letters] Mean ± Standard Deviation
Change from Baseline at Month 3 (n=284, 84, 25)	-2.9 ± 8.9	-2.9 ± 11.0	0.1 ± 6.6	-2.7 ± 9.3
Change from Baseline at Month 6 (n=519, 149, 46)	-3.4 ± 8.8	-1.6 ± 10.5	0.3 ± 7.0	-2.8 ± 9.1
Change from Baseline at Month 9 (n=490, 149, 38)	-4.4 ± 10.8	-1.7 ± 11.3	-2.2 ± 7.5	-3.7 ± 10.8
Change from Baseline at Month 12 (n=481, 142, 38)	-5.2 ± 11.1	-2.3 ± 11.5	-3.2 ± 8.0	-4.5 ± 11.1
Change from Baseline at Month 15 (n=447, 138, 31)	-5.6 ± 10.8	-2.2 ± 12.4	-3.0 ± 8.9	-4.7 ± 11.2
Change from Baseline at Month 18 (n=420, 135, 28)	-6.4 ± 11.9	-2.0 ± 12.5	-4.4 ± 9.5	-5.3 ± 12.1
Change from Baseline at Month 21 (n=405, 129, 28)	-7.9 ± 13.0	-2.1 ± 13.3	-3.5 ± 10.8	-6.3 ± 13.2
Change from Baseline at Month 24 (n=388, 127, 27)	-8.1 ± 13.0	-2.0 ± 13.5	-2.9 ± 8.5	-6.4 ± 13.2

No statistical analysis provided for Change From Baseline in Best Corrected Visual Acuity (BCVA) at a Starting Test Distance of 2 Meters

5. Secondary:

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 ]

Measure Type	Secondary
Measure Title	Change From Baseline in Best Corrected Visual Acuity at a Starting Test Distance of 4 Meters
Measure Description	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.
Time Frame	Extension study baseline, Months 12 and 24
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Enrolled participants. Observed data were used with no imputation. The number of participants for whom data was available for analyses is represented by "n".

Reporting Groups

	Description
Ranibizumab Initial Group	In this extension study participants received Ranibizumab 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) for 24 months. Participants in this group were initially enrolled and received treatment with Ranibizumab in one of the following studies: FVF2428g (NCT00056823), FVF2587g (NCT00061594) or FVF2598g (NCT0056823).
Ranibizumab Crossover Group	In this extension study participants received Ranibizumab 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) for 24 months. Participants in this group were enrolled but did not initially receive Ranibizumab in Study FVF2428g (NCT00056823), Study FVF2587g (NCT00061594) or Study FVF2598g (NCT00056836) and then crossed over to receive Ranibizumab either in the initial study or this extension study.
Ranibizumab Untreated Group	In this extension study participants did not receive Ranibizumab. Participants in this group were enrolled in one of the following studies: FVF2428g (NCT00056823), FVF2587g (NCT00061594) or FVF2598g (NCT0056823) but did not receive treatment with Ranibizumab in that study or this extension study.
Total	All enrolled subjects

Measured Values

	Ranibizumab Initial Group	Ranibizumab Crossover Group	Ranibizumab Untreated Group	Total
Number of Participants Analyzed [units: participants]	600	190	63	853
Change From Baseline in Best Corrected Visual Acuity at a Starting Test Distance of 4 Meters [units: letters] Mean ± Standard Deviation
Change from Baseline at Month 12 (n=446,133,35)	-5.4 ± 11.8	-1.3 ± 11.8	-3.2 ± 7.2	-4.4 ± 11.7
Change from Baseline at Month 24 (n=352,122,25)	-7.5 ± 12.3	-0.8 ± 13.0	-3.1 ± 8.2	-5.7 ± 12.7

No statistical analysis provided for Change From Baseline in Best Corrected Visual Acuity at a Starting Test Distance of 4 Meters

Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Genentech
Organization: Genentech
e-mail: ctg-post-d@gene.com

No publications provided

Responsible Party:	Genentech
ClinicalTrials.gov Identifier:	NCT00379795 History of Changes
Other Study ID Numbers:	FVF3426g (Cohort 1)
Study First Received:	September 21, 2006
Results First Received:	April 1, 2011
Last Updated:	January 30, 2013
Health Authority:	United States: Food and Drug Administration