Trial · NCT01846299

To Assess the Efficacy and Safety of Intravitreal Ranibizumab in People With Vision Loss Due to Macular Edema

NCT01846299, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2016-05-23

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. To Assess the Efficacy and Safety of Intravitreal Ranibizumab in People With Vision Loss Due to Macular Edema. Trials, record NCT01846299. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01846299

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Trial

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

Title: To Assess the Efficacy and Safety of Intravitreal Ranibizumab in People With Vision Loss Due to Macular Edema
NCT number: NCT01846299
Status: Completed
Phases: Phase 3
Enrollment: 181 participants, actual
Lead sponsor: Novartis Pharmaceuticals
Conditions: Macular Edema (ME)
Interventions: Sham control, Ranibizumab
First posted: 2013-05-03
Last updated: 2016-05-23
Other registries' IDs: eudract:2012-005418-20
Results first posted: 2016-05-23

Source ClinicalTrials.gov

Registered outcomes14

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

List	Outcome	Time frame	Description
Primary	Change From Baseline in Best-corrected Visual Acuity (BCVA) in Study Eye	Baseline, Month 2	BCVA was assessed in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity (VA) testing charts at an initial testing distance of 4 meters. A positive change from baseline indicated improvement.
Secondary	Change From Baseline in BCVA in Study Eye up to Month 2	Baseline, Month 1, Month 2	BCVA was assessed in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity (VA) testing charts at an initial testing distance of 4 meters. A positive change from baseline indicated improvement.
Secondary	Change From Baseline in Central Subfield Thickness (CSFT) in Study Eye	Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12	CSFT wasassessed by optical coherence tomography (OCT). A negative change from baseline indicates improvement.
Secondary	Change From Baseline in Central Subfield Volume (CSFV) in Study Eye	Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12	CSFV was assessed OCT. A negative change from baseline indicates improvement.
Secondary	Number of Participants With Presence or Absence of Intra-retinal Fluid in Study Eye Compared to Baseline	Month 2, Month 6, Month 12	The presence of intra-retinal fluid was assessed by OCT.
Secondary	Number of Participants With Presence or Absence of Subretinal Fluid in Study Eye Compared to Baseline	Month 2, Month 6, Month 12	The presence of subretinal fluid was assessed by OCT.
Secondary	Number of Participants With Presence of Active Macular Edema (ME) Leakage	Month 2	The presence of active ME leakage was assessed by fluorescein angiography (FA).
Secondary	Number of Participants Requiring Rescue Treatment at Month 1	Month 1	Rescue treatment with laser photocoagulation or periocular treatment could be administered at Month 1 only if the participant had a visual acuity loss of \> 5 letters due to disease activity from baseline to Month 1.
Secondary	Average Change From Baseline in BCVA	Baseline (BL), month 1 through month 6, month 1 through month 12	BCVA was assessed in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity (VA) testing charts at an initial testing distance of 4 meters. A positive change from baseline indicated improvement.
Secondary	Number of Participants With ≥ 1, ≥ 5, ≥ 10 and ≥ 15 Letters Gain or Reaching 84 Letters	Month 2, Month 6 , Month 12	VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using ETDRS-like visual acuity testing charts at a testing distance of 4 meters.

1 to 10 of 14Source ClinicalTrials.gov

See all 14 registered outcomes

Outcomes14

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline in Best-corrected Visual Acuity (BCVA) in Study Eye	Baseline, Month 2	Full analysis set: The full analysis set included all randomized participants who received at least one dose of study treatment.	letters	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in BCVA in Study Eye up to Month 2	Baseline, Month 1, Month 2	The full analysis set (FAS) was considered for the analysis. The FAS. The FAS included all randomized participants who received at least one dose of study treatment. Only participants of the FAS, who had data at baseline and the specific post-baseline time point, were included in the analysis for that time point.	letters	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Central Subfield Thickness (CSFT) in Study Eye	Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12	The full analysis set (FAS) was considered for the analysis. The FAS included all randomized participants who received at least one dose of study treatment. Only participants of the FAS, who had data at baseline and the specific post-baseline time point, were included in the analysis for that time point.	micrometers (um)	MEAN
SECONDARY	Change From Baseline in Central Subfield Volume (CSFV) in Study Eye	Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12	The full analysis set (FAS) was considered for the analysis. The FAS included all randomized participants who received at least one dose of study treatment. Only participants of the FAS, who had data at baseline and the specific post-baseline time point, were included in the analysis for that time point.	microliters (ul)	MEAN
SECONDARY	Number of Participants With Presence or Absence of Intra-retinal Fluid in Study Eye Compared to Baseline	Month 2, Month 6, Month 12	The FAS was considered for the analysis. The FAS included all randomized participants who received at least one dose of study treatment. Only participants (n), with values 'Absent' or 'Definite' for both the baseline and corresponding post-baseline time point, were included in the analysis.	Participants	NUMBER
SECONDARY	Number of Participants With Presence or Absence of Subretinal Fluid in Study Eye Compared to Baseline	Month 2, Month 6, Month 12	The FAS was considered for the analysis. The FAS included all randomized participants who received at least one dose of study treatment. Only participants (n), with values 'Absent' or 'Definite' for both the baseline and corresponding post-baseline time point, were included in the analysis.	Participants	NUMBER
SECONDARY	Number of Participants With Presence of Active Macular Edema (ME) Leakage	Month 2	The FAS was used this analysis. The FAS included randomized participants who received at least one dose of study treatment.	Participants	NUMBER
SECONDARY	Number of Participants Requiring Rescue Treatment at Month 1	Month 1	The FAS was used for this analysis. The FAS included all randomized participants who received at least one dose of study treatment.	Participants	NUMBER
SECONDARY	Average Change From Baseline in BCVA	Baseline (BL), month 1 through month 6, month 1 through month 12	The FAS was used for this analysis. The FAS included randomized participants who received at least one dose of study medication.	letters	MEAN
SECONDARY	Number of Participants With ≥ 1, ≥ 5, ≥ 10 and ≥ 15 Letters Gain or Reaching 84 Letters	Month 2, Month 6 , Month 12	The full analysis set (FAS) was considered for the analysis. The FAS included all randomized participants who received at least one dose of study treatment. Only participants of the FAS, who had data at baseline and the specific post-baseline time point, were included in the analysis for that time point.	Participants	NUMBER

1 to 10 of 14Source ClinicalTrials.gov

See all 14 outcomes

Results by group212

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

Outcome	Group	Category	Value	Spread	Units
Change From Baseline in Best-corrected Visual Acuity (BCVA) in Study Eye	Ranibizumab		5.7	Standard Error 0.81	letters
Change From Baseline in Best-corrected Visual Acuity (BCVA) in Study Eye	Sham With Ranibizumab		2.9	Standard Error 0.89	letters
Change From Baseline in BCVA in Study Eye up to Month 2	Ranibizumab	Month 1 (n=116,59)	4.7	Standard Error 0.70	letters
Change From Baseline in BCVA in Study Eye up to Month 2	Sham With Ranibizumab	Month 1 (n=116,59)	1.4	Standard Error 0.98	letters
Change From Baseline in BCVA in Study Eye up to Month 2	Ranibizumab	Month 2 (n=114,59)	5.8	Standard Error 0.76	letters
Change From Baseline in BCVA in Study Eye up to Month 2	Sham With Ranibizumab	Month 2 (n=114,59)	2.8	Standard Error 1.05	letters
Change From Baseline in Central Subfield Thickness (CSFT) in Study Eye	Ranibizumab	Month 1 (n=112,59)	-83.6	Standard Deviation 127.45	micrometers (um)
Change From Baseline in Central Subfield Thickness (CSFT) in Study Eye	Sham With Ranibizumab	Month 1 (n=112,59)	-14.3	Standard Deviation 97.36	micrometers (um)
Change From Baseline in Central Subfield Thickness (CSFT) in Study Eye	Ranibizumab	Month 2 (n=112,59)	-82.5	Standard Deviation 140.06	micrometers (um)
Change From Baseline in Central Subfield Thickness (CSFT) in Study Eye	Sham With Ranibizumab	Month 2 (n=112,59)	-30.6	Standard Deviation 102.77	micrometers (um)

1 to 10 of 212Source ClinicalTrials.gov

See all 212 results by group

Participant flow10

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Ranibizumab	118
Overall Study	STARTED	Sham	60
Overall Study	Full Analysis Set	Ranibizumab	117
Overall Study	Full Analysis Set	Sham	60
Overall Study	Safety Set	Ranibizumab	119
Overall Study	Safety Set	Sham	58
Overall Study	COMPLETED	Ranibizumab	106
Overall Study	COMPLETED	Sham	50
Overall Study	NOT COMPLETED	Ranibizumab	12
Overall Study	NOT COMPLETED	Sham	10

Source ClinicalTrials.gov

Adverse events147

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	Conjunctival haemorrhage (Study eye)	Eye disorders	Ranibizumab 0.5mg	11	119
other	Conjunctival haemorrhage (Study eye)	Eye disorders	Sham With Ranibizumab 0.5mg	7	56
other	Conjunctival haemorrhage (Study eye)	Eye disorders	Sham Without Ranibizumab 0.5mg	0	2
other	Cystoid macular oedema (Study eye)	Eye disorders	Ranibizumab 0.5mg	6	119
other	Cystoid macular oedema (Study eye)	Eye disorders	Sham With Ranibizumab 0.5mg	0	56
other	Cystoid macular oedema (Study eye)	Eye disorders	Sham Without Ranibizumab 0.5mg	0	2
other	Dry eye (Study eye)	Eye disorders	Ranibizumab 0.5mg	6	119
other	Dry eye (Study eye)	Eye disorders	Sham With Ranibizumab 0.5mg	1	56
other	Dry eye (Study eye)	Eye disorders	Sham Without Ranibizumab 0.5mg	0	2
other	Eye pain (Study eye)	Eye disorders	Ranibizumab 0.5mg	10	119

1 to 10 of 147Source ClinicalTrials.gov

See all 147 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Ranibizumab 0.5mg
Total, all-cause mortality	Sham With Ranibizumab 0.5mg
Total, all-cause mortality	Sham Without Ranibizumab 0.5mg
Total, other adverse events	Ranibizumab 0.5mg	58	119
Total, other adverse events	Sham With Ranibizumab 0.5mg	21	56
Total, other adverse events	Sham Without Ranibizumab 0.5mg	0	2
Total, serious adverse events	Ranibizumab 0.5mg	15	119
Total, serious adverse events	Sham With Ranibizumab 0.5mg	6	56
Total, serious adverse events	Sham Without Ranibizumab 0.5mg	1	2

Source ClinicalTrials.gov

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 comparisons2

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

Comparison	Source
Ranibizumab vs Sham With Ranibizumab: Number of Participants Requiring Rescue Treatment at Month 1	Trial comparisons
Ranibizumab vs Sham With Ranibizumab: Number of Participants With Presence of Active Macular Edema (ME) Leakage	Trial comparisons

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/NCT01846299

GET https://conductscience.org/api/trials/v1/NCT01846299/results?page=2

API reference For AI assistants