Trial · NCT01469156

Safety Study of 2.0mg Lucentis to Treat Polypoidal Choroidal Vasculopathy

NCT01469156, Phase 1, Phase 2, Completed, Southeast Retina Center, Georgia; results first posted 2022-12-12

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Safety Study of 2.0mg Lucentis to Treat Polypoidal Choroidal Vasculopathy. Trials, record NCT01469156. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01469156

On this page

Trial

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

Title: Safety Study of 2.0mg Lucentis to Treat Polypoidal Choroidal Vasculopathy
NCT number: NCT01469156
Status: Completed
Phases: Phase 1, Phase 2
Enrollment: 20 participants, actual
Lead sponsor: Southeast Retina Center, Georgia
Conditions: Polypoidal Choroidal Vasculopathy
Interventions: ranibizumab 0.5 or 2.0 mg/0.05 cc
First posted: 2011-11-10
Last updated: 2022-12-12
Results first posted: 2022-12-12

Source ClinicalTrials.gov

Registered outcomes13

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

List	Outcome	Time frame	Description
Primary	Incidence and Severity of Ocular and Systemic Adverse Events Will be Compared Between the 2.0mg or 1.0mg (HIGH DOSE) and 0.5 mg Groups.	2 years	Examples include 30 letter loss, major subretinal hemorrhage, involving 75% or more clinical macula (arcade to arcade), disease related vitreous hemorrhage, injection-related endophthalmitis, retinal detachment, vitreous hemorrhage, study drug/procedure - related uveitis, incidence and severity of other adverse events, as identified by physical examination, subject reporting, and changes in vital signs.
Secondary	Mean Best Corrected Visual Acuity Letter Change at 4 Meters Between Baseline and 12 Months	12 months
Secondary	Change in Mean Central Foveal Thickness From Baseline	12 Months
Secondary	Mean Change From Baseline in Total Area of FA CNV Leakage Over 12 Months	12 Months
Secondary	Number of Participants at Month 3 With Best Corrected Visual Acuity Gain of 5, 10, and 15 or More Letters	3 Months
Secondary	Number of Participants at Month 6 With Best Corrected Visual Acuity Gain of 5, 10, and 15 or More Letters	6 months
Secondary	Number of Participants at Month 9 With Best Corrected Visual Acuity Gain of 5, 10, and 15 or More Letters	9 Months
Secondary	Number of Participants at Month 12 With Best Corrected Visual Acuity Gain of 5, 10, and 15 or More Letters	12 Months
Secondary	Mean Change Best Corrected Visual Acuity at 4 Meters at Baseline, Month 3, Month 6, Month 9, and Month 12	12 months
Secondary	Number of Participants at Month 3 With Best Corrected Visual Acuity Loss at 4 Meters of 5, 10 and 15 or More Letters	3 months

1 to 10 of 13Source ClinicalTrials.gov

See all 13 registered outcomes

Outcomes13

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Incidence and Severity of Ocular and Systemic Adverse Events Will be Compared Between the 2.0mg or 1.0mg (HIGH DOSE) and 0.5 mg Groups.	2 years		Adverse events	NUMBER
SECONDARY	Mean Best Corrected Visual Acuity Letter Change at 4 Meters Between Baseline and 12 Months	12 months	Randomized in a 3:1 ratio - number in participant flow is 20	letters	MEAN
SECONDARY	Change in Mean Central Foveal Thickness From Baseline	12 Months	Randomized in a 3:1 ratio	um	MEAN
SECONDARY	Mean Change From Baseline in Total Area of FA CNV Leakage Over 12 Months	12 Months	Randomized in a 3:1 ratio	mm^2	MEAN
SECONDARY	Number of Participants at Month 3 With Best Corrected Visual Acuity Gain of 5, 10, and 15 or More Letters	3 Months	Randomized in a 3:1 ratio - number in participant flow is 20	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants at Month 6 With Best Corrected Visual Acuity Gain of 5, 10, and 15 or More Letters	6 months	Randomized in a 3:1 ratio - number in participant flow is 20	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants at Month 9 With Best Corrected Visual Acuity Gain of 5, 10, and 15 or More Letters	9 Months	Randomized in a 3:1 ratio - number in participant flow is 20	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants at Month 12 With Best Corrected Visual Acuity Gain of 5, 10, and 15 or More Letters	12 Months	Randomized in a 3:1 ratio - number in participant flow is 20	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Mean Change Best Corrected Visual Acuity at 4 Meters at Baseline, Month 3, Month 6, Month 9, and Month 12	12 months	Randomized in a 3:1 ratio - number in participant flow is 20	letters	MEAN
SECONDARY	Number of Participants at Month 3 With Best Corrected Visual Acuity Loss at 4 Meters of 5, 10 and 15 or More Letters	3 months	Randomized in a 3:1 ratio - number in participant flow is 20	Participants	COUNT_OF_PARTICIPANTS

1 to 10 of 13Source ClinicalTrials.gov

See all 13 outcomes

Results by group96

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

Outcome	Group	Category	Value	Units
Incidence and Severity of Ocular and Systemic Adverse Events Will be Compared Between the 2.0mg or 1.0mg (HIGH DOSE) and 0.5 mg Groups.	Control Group: Ranibizumab 0.5mg	Total Ocular and Notable Systemic AEs	4	Adverse events
Incidence and Severity of Ocular and Systemic Adverse Events Will be Compared Between the 2.0mg or 1.0mg (HIGH DOSE) and 0.5 mg Groups.	Ranibizumab 1.0mg or 2.0mg	Total Ocular and Notable Systemic AEs	24	Adverse events
Incidence and Severity of Ocular and Systemic Adverse Events Will be Compared Between the 2.0mg or 1.0mg (HIGH DOSE) and 0.5 mg Groups.	Control Group: Ranibizumab 0.5mg	Blurred or decreased vision	0	Adverse events
Incidence and Severity of Ocular and Systemic Adverse Events Will be Compared Between the 2.0mg or 1.0mg (HIGH DOSE) and 0.5 mg Groups.	Ranibizumab 1.0mg or 2.0mg	Blurred or decreased vision	6	Adverse events
Incidence and Severity of Ocular and Systemic Adverse Events Will be Compared Between the 2.0mg or 1.0mg (HIGH DOSE) and 0.5 mg Groups.	Control Group: Ranibizumab 0.5mg	Floaters	2	Adverse events
Incidence and Severity of Ocular and Systemic Adverse Events Will be Compared Between the 2.0mg or 1.0mg (HIGH DOSE) and 0.5 mg Groups.	Ranibizumab 1.0mg or 2.0mg	Floaters	4	Adverse events
Incidence and Severity of Ocular and Systemic Adverse Events Will be Compared Between the 2.0mg or 1.0mg (HIGH DOSE) and 0.5 mg Groups.	Control Group: Ranibizumab 0.5mg	Dark Spots	0	Adverse events
Incidence and Severity of Ocular and Systemic Adverse Events Will be Compared Between the 2.0mg or 1.0mg (HIGH DOSE) and 0.5 mg Groups.	Ranibizumab 1.0mg or 2.0mg	Dark Spots	3	Adverse events
Incidence and Severity of Ocular and Systemic Adverse Events Will be Compared Between the 2.0mg or 1.0mg (HIGH DOSE) and 0.5 mg Groups.	Control Group: Ranibizumab 0.5mg	Injection site or ocular pain	0	Adverse events
Incidence and Severity of Ocular and Systemic Adverse Events Will be Compared Between the 2.0mg or 1.0mg (HIGH DOSE) and 0.5 mg Groups.	Ranibizumab 1.0mg or 2.0mg	Injection site or ocular pain	2	Adverse events

1 to 10 of 96Source ClinicalTrials.gov

See all 96 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Ranibizumab 1.0 or 2.0 mg (HIGH DOSE)	15
Overall Study	STARTED	Ranibizumab 0.5 mg	5
Overall Study	COMPLETED	Ranibizumab 1.0 or 2.0 mg (HIGH DOSE)	15
Overall Study	COMPLETED	Ranibizumab 0.5 mg	5
Overall Study	NOT COMPLETED	Ranibizumab 1.0 or 2.0 mg (HIGH DOSE)	0
Overall Study	NOT COMPLETED	Ranibizumab 0.5 mg	0

Source ClinicalTrials.gov

Adverse events18

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	Events
other	Affected vision	Eye disorders	Control Group: Ranibizumab 0.5mg	1	5	3
other	Affected vision	Eye disorders	Ranibizumab 1.0mg or 2.0mg	6	15	14
other	Intravitreal injection side effects	Eye disorders	Control Group: Ranibizumab 0.5mg	0	5	0
other	Intravitreal injection side effects	Eye disorders	Ranibizumab 1.0mg or 2.0mg	2	15	3
other	Increased cataract	Eye disorders	Control Group: Ranibizumab 0.5mg	0	5	0
other	Increased cataract	Eye disorders	Ranibizumab 1.0mg or 2.0mg	2	15	2
other	Superior hemorrhage	Eye disorders	Control Group: Ranibizumab 0.5mg	0	5	0
other	Superior hemorrhage	Eye disorders	Ranibizumab 1.0mg or 2.0mg	1	15	1
other	Increased Choroidal neovascularization	Eye disorders	Control Group: Ranibizumab 0.5mg	0	5	0
other	Increased Choroidal neovascularization	Eye disorders	Ranibizumab 1.0mg or 2.0mg	1	15	1

1 to 10 of 18Source ClinicalTrials.gov

See all 18 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Control Group: Ranibizumab 0.5mg
Total, all-cause mortality	Ranibizumab 1.0mg or 2.0mg
Total, other adverse events	Control Group: Ranibizumab 0.5mg	2	5
Total, other adverse events	Ranibizumab 1.0mg or 2.0mg	9	15
Total, serious adverse events	Control Group: Ranibizumab 0.5mg	0	5
Total, serious adverse events	Ranibizumab 1.0mg or 2.0mg	0	15

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 comparisons1

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

Comparison
Control Group: Ranibizumab 0.5mg vs Ranibizumab 1.0mg or 2.0mg: serious adverse events

Source 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/NCT01469156

GET https://conductscience.org/api/trials/v1/NCT01469156/results?page=2

API reference For AI assistants