Trial · NCT00436553

Efficacy/Safety of Verteporfin Photodynamic Therapy and Ranibizumab Compared With Ranibizumab in Patients With Subfoveal Choroidal Neovascularization

NCT00436553, Phase 3, Completed, Novartis; results first posted 2011-04-19

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Efficacy/Safety of Verteporfin Photodynamic Therapy and Ranibizumab Compared With Ranibizumab in Patients With Subfoveal Choroidal Neovascularization. Trials, record NCT00436553. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00436553

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Trial

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

Title: Efficacy/Safety of Verteporfin Photodynamic Therapy and Ranibizumab Compared With Ranibizumab in Patients With Subfoveal Choroidal Neovascularization
NCT number: NCT00436553
Status: Completed
Phases: Phase 3
Enrollment: 321 participants, actual
Lead sponsor: Novartis
Conditions: Macular Degeneration, Choroidal Neovascularization
Interventions: Verteporfin Photodynamic Therapy, Ranibizumab, Verteporfin Placebo, Ranibizumab Placebo
First posted: 2007-02-19
Last updated: 2011-04-19
Results first posted: 2011-04-19
Limitations and caveats: Shorten the study duration from 24 months to 12 months based on results of the European combination study MONT BLANC (CBPD952A2309).

Source ClinicalTrials.gov

Registered outcomes5

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

List	Outcome	Time frame	Description
Primary	Mean Change From Baseline in Best-corrected Visual Acuity (BCVA) of the Study Eye at Month 12	Baseline and Month 12	BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. An increase in the VA score indicates improvement in visual acuity.
Primary	Percent of Patients With a Treatment-free Interval of at Least 3 Months Following the Month 2 Visit	Month 2 up to Month 11	The number of patients with a ranibizumab treatment-free interval, ie, no active ranibizumab treatments for at least 3 months duration (at least 2 consecutive monthly visits), anytime following the Month 2 ranibizumab treatment. Only active ranibizumab treatments were considered.
Secondary	Change From Baseline in Total Area of Leakage of the Study Eye at Month 12	Baseline and Month 12	Total area of leakage of the study eye was assessed at the Central Reading Center (CRC) using Fluorescein angiography (FA).
Secondary	Percentage of Patients With Fluorescein Leakage in the Study Eye at Month 12	Month 12	The percentage of patients with leakage of the study eye was assessed at the Central Reading Center (CRC) using Fluorescein angiography (FA).
Secondary	Change From Baseline in Central Retinal Thickness at Month 12	Baseline and Month 12	Optical coherence tomography was performed in the study eyes and the evaluations of the images were performed by the central reading center.

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	Mean Change From Baseline in Best-corrected Visual Acuity (BCVA) of the Study Eye at Month 12	Baseline and Month 12	The Full analysis set (FAS) consisting of all randomized patients that received at least one application of study drug and had at least one post-baseline assessment for BCVA in the study eye. Last observation carried forward (LOCF) was utilized.	Letters	MEAN
SECONDARY	Change From Baseline in Total Area of Leakage of the Study Eye at Month 12	Baseline and Month 12	Full analysis set (FAS), observed data.	mm^2	MEAN
SECONDARY	Percentage of Patients With Fluorescein Leakage in the Study Eye at Month 12	Month 12	Full analysis set (FAS), observed data.	Percentage of participants	NUMBER
SECONDARY	Change From Baseline in Central Retinal Thickness at Month 12	Baseline and Month 12	Full analysis set (FAS), observed data.	micrometer	MEAN
PRIMARY	Percent of Patients With a Treatment-free Interval of at Least 3 Months Following the Month 2 Visit	Month 2 up to Month 11	Full analysis set (FAS) - Only the combination groups were analyzed. The percent of subjects with a ranibizumab treatment-free interval of at least 3 months duration following the Month 2 ranibizumab treatment was calculated using the subjects still in the study at Month 5.	Percent of participants	NUMBER

Source ClinicalTrials.gov

Results by group32

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

Outcome	Group	Category	Value	Spread	Units
Mean Change From Baseline in Best-corrected Visual Acuity (BCVA) of the Study Eye at Month 12	Verteporfin SF + Ranibizumab	Baseline	53.7	Standard Deviation 13.52	Letters
Mean Change From Baseline in Best-corrected Visual Acuity (BCVA) of the Study Eye at Month 12	Verteporfin RF + Ranibizumab	Baseline	54.6	Standard Deviation 12.78	Letters
Mean Change From Baseline in Best-corrected Visual Acuity (BCVA) of the Study Eye at Month 12	Ranibizumab Monotherapy	Baseline	54.8	Standard Deviation 13.55	Letters
Mean Change From Baseline in Best-corrected Visual Acuity (BCVA) of the Study Eye at Month 12	Verteporfin SF + Ranibizumab	Month 12	59.0	Standard Deviation 17.47	Letters
Mean Change From Baseline in Best-corrected Visual Acuity (BCVA) of the Study Eye at Month 12	Verteporfin RF + Ranibizumab	Month 12	59.0	Standard Deviation 18.03	Letters
Mean Change From Baseline in Best-corrected Visual Acuity (BCVA) of the Study Eye at Month 12	Ranibizumab Monotherapy	Month 12	63.0	Standard Deviation 18.88	Letters
Mean Change From Baseline in Best-corrected Visual Acuity (BCVA) of the Study Eye at Month 12	Verteporfin SF + Ranibizumab	Change from baseline	5.3	Standard Deviation 15.66	Letters
Mean Change From Baseline in Best-corrected Visual Acuity (BCVA) of the Study Eye at Month 12	Verteporfin RF + Ranibizumab	Change from baseline	4.4	Standard Deviation 15.47	Letters
Mean Change From Baseline in Best-corrected Visual Acuity (BCVA) of the Study Eye at Month 12	Ranibizumab Monotherapy	Change from baseline	8.1	Standard Deviation 15.09	Letters
Change From Baseline in Total Area of Leakage of the Study Eye at Month 12	Verteporfin SF + Ranibizumab	Baseline	6.654	Standard Deviation 4.0956	mm^2

1 to 10 of 32Source ClinicalTrials.gov

See all 32 results by group

Participant flow9

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Verteporfin SF + Ranibizumab	104
Overall Study	STARTED	Verteporfin RF + Ranibizumab	105
Overall Study	STARTED	Ranibizumab Monotherapy	112
Overall Study	COMPLETED	Verteporfin SF + Ranibizumab	91
Overall Study	COMPLETED	Verteporfin RF + Ranibizumab	93
Overall Study	COMPLETED	Ranibizumab Monotherapy	102
Overall Study	NOT COMPLETED	Verteporfin SF + Ranibizumab	13
Overall Study	NOT COMPLETED	Verteporfin RF + Ranibizumab	12
Overall Study	NOT COMPLETED	Ranibizumab Monotherapy	10

Source ClinicalTrials.gov

Adverse events501

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	Verteporfin SF + Ranibizumab	1	104
other	Anaemia	Blood and lymphatic system disorders	Verteporfin RF + Ranibizumab	7	106
other	Anaemia	Blood and lymphatic system disorders	Ranibizumab Monotherapy	5	111
other	Blepharitis (Study eye)	Eye disorders	Verteporfin SF + Ranibizumab	6	104
other	Blepharitis (Study eye)	Eye disorders	Verteporfin RF + Ranibizumab	3	106
other	Blepharitis (Study eye)	Eye disorders	Ranibizumab Monotherapy	5	111
other	Cataract (Fellow eye)	Eye disorders	Verteporfin SF + Ranibizumab	4	104
other	Cataract (Fellow eye)	Eye disorders	Verteporfin RF + Ranibizumab	4	106
other	Cataract (Fellow eye)	Eye disorders	Ranibizumab Monotherapy	6	111
other	Cataract (Study eye)	Eye disorders	Verteporfin SF + Ranibizumab	6	104

1 to 10 of 501Source ClinicalTrials.gov

See all 501 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Verteporfin SF + Ranibizumab
Total, all-cause mortality	Verteporfin RF + Ranibizumab
Total, all-cause mortality	Ranibizumab Monotherapy
Total, other adverse events	Verteporfin SF + Ranibizumab	85	104
Total, other adverse events	Verteporfin RF + Ranibizumab	81	106
Total, other adverse events	Ranibizumab Monotherapy	87	111
Total, serious adverse events	Verteporfin SF + Ranibizumab	32	104
Total, serious adverse events	Verteporfin RF + Ranibizumab	29	106
Total, serious adverse events	Ranibizumab Monotherapy	41	111

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
22444829	DERIVED

Source PubMed

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.

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