Trial · NCT00433017

Verteporfin Photodynamic Therapy Administered in Conjunction With Ranibizumab in Patients With Subfoveal Choroidal Neovascularization Secondary to Age-related Macular Degeneration (AMD)

NCT00433017, Phase 2, Phase 3, Terminated, Novartis; results first posted 2011-02-04

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Verteporfin Photodynamic Therapy Administered in Conjunction With Ranibizumab in Patients With Subfoveal Choroidal Neovascularization Secondary to Age-related Macular Degeneration (AMD). Trials, record NCT00433017. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00433017

On this page

Trial

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

Title: Verteporfin Photodynamic Therapy Administered in Conjunction With Ranibizumab in Patients With Subfoveal Choroidal Neovascularization Secondary to Age-related Macular Degeneration (AMD)
NCT number: NCT00433017
Status: Terminated
Phases: Phase 2, Phase 3
Enrollment: 255 participants, actual
Lead sponsor: Novartis
Conditions: Macular Degeneration, Choroidal Neovascularization
Interventions: Verteporfin Photodynamic Therapy, Ranibizumab, Placebo
First posted: 2007-02-09
Last updated: 2011-04-21
Results first posted: 2011-02-04

Source ClinicalTrials.gov

Registered outcomes5

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) 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 Participants With a Treatment-free Interval of at Least 3 Months Following the Month 2 Visit	Month 2 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	Percentage of Patients With Fluorescein Leakage in the Study Eye at Month 12	Month 12	The proportion of patients with leakage of the study eye was assessed at the Central Reading Center (CRC) using Fluorescein angiography (FA).
Secondary	Mean Change in Total Area of Leakage (Observed) of the Study Eye at Month 12	Baseline and Month 12	Fluorescein angiography (FA) was used to assess the mean change of leakage of the study eye at the Central Reading Center (CRC). A negative change from baseline indicates improvement, ie, less leakage.
Secondary	Mean Change in Central Retinal Thickness of the Study Eye at Month 12	Baseline and Month 12	Optical coherence tomography (OCT) was used to assess the mean change in retinal thickness of the study eye at the Central Reading Center (CRC). A negative change from baseline indicates improvement, ie, less thickness.

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	Change From Baseline in Best-corrected Visual Acuity (BCVA) at Month 12.	Baseline and Month 12	Performed on the Full analysis set (FAS) using the Last Observation Carried Forward (LOCF) approach for imputing missing data. FAS consisted of all patients as randomized that received at least one application of study drug and had at least one post-baseline assessment for best corrected visual acuity in the study eye.	Letters	MEAN
PRIMARY	Percent of Participants With a Treatment-free Interval of at Least 3 Months Following the Month 2 Visit	Month 2 to Month 11	Full analysis set. Includes number of participants in the treatment group with at least one visit assessment of re-treatment.	Percentage of Participants	NUMBER
SECONDARY	Percentage of Patients With Fluorescein Leakage in the Study Eye at Month 12	Month 12	The Full Analysis Set (FAS) based on observed data.	Percentage of participants	NUMBER
SECONDARY	Mean Change in Total Area of Leakage (Observed) of the Study Eye at Month 12	Baseline and Month 12	Full analysis set based on observed data.	mm^2	MEAN
SECONDARY	Mean Change in Central Retinal Thickness of the Study Eye at Month 12	Baseline and Month 12	Full analysis set, LOCF	μm	MEAN

Source ClinicalTrials.gov

Results by group22

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) at Month 12.	Verteporfin + Ranibizumab	Baseline	54.6	Standard Deviation 13.5	Letters
Change From Baseline in Best-corrected Visual Acuity (BCVA) at Month 12.	Ranibizumab	Baseline	55.1	Standard Deviation 12.3	Letters
Change From Baseline in Best-corrected Visual Acuity (BCVA) at Month 12.	Verteporfin + Ranibizumab	Month 12	57.1	Standard Deviation 18.3	Letters
Change From Baseline in Best-corrected Visual Acuity (BCVA) at Month 12.	Ranibizumab	Month 12	59.4	Standard Deviation 18.8	Letters
Change From Baseline in Best-corrected Visual Acuity (BCVA) at Month 12.	Verteporfin + Ranibizumab	Change from Baseline	2.5	Standard Deviation 14.82	Letters
Change From Baseline in Best-corrected Visual Acuity (BCVA) at Month 12.	Ranibizumab	Change from Baseline	4.4	Standard Deviation 15.92	Letters
Percent of Participants With a Treatment-free Interval of at Least 3 Months Following the Month 2 Visit	Verteporfin + Ranibizumab		95.8		Percentage of Participants
Percent of Participants With a Treatment-free Interval of at Least 3 Months Following the Month 2 Visit	Ranibizumab		92.2		Percentage of Participants
Percentage of Patients With Fluorescein Leakage in the Study Eye at Month 12	Verteporfin + Ranibizumab		28.9		Percentage of participants
Percentage of Patients With Fluorescein Leakage in the Study Eye at Month 12	Ranibizumab		25.2		Percentage of participants

1 to 10 of 22Source ClinicalTrials.gov

See all 22 results by group

Participant flow8

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Verteporfin + Ranibizumab	122
Overall Study	STARTED	Ranibizumab	133
Overall Study	Completed 12 Month Phase	Verteporfin + Ranibizumab	114
Overall Study	Completed 12 Month Phase	Ranibizumab	126
Overall Study	COMPLETED	Verteporfin + Ranibizumab	26
Overall Study	COMPLETED	Ranibizumab	32
Overall Study	NOT COMPLETED	Verteporfin + Ranibizumab	96
Overall Study	NOT COMPLETED	Ranibizumab	101

Source ClinicalTrials.gov

Adverse events182

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	Verteporfin + Ranibizumab	4	122
other	CONJUNCTIVAL HAEMORRHAGE (Study eye)	Eye disorders	Ranibizumab	10	133
other	EYE PAIN (Study eye)	Eye disorders	Verteporfin + Ranibizumab	10	122
other	EYE PAIN (Study eye)	Eye disorders	Ranibizumab	8	133
other	MACULAR DEGENERATION (Fellow eye)	Eye disorders	Verteporfin + Ranibizumab	4	122
other	MACULAR DEGENERATION (Fellow eye)	Eye disorders	Ranibizumab	8	133
other	OCULAR HYPERAEMIA (Study eye)	Eye disorders	Verteporfin + Ranibizumab	7	122
other	OCULAR HYPERAEMIA (Study eye)	Eye disorders	Ranibizumab	10	133
other	RETINAL HAEMORRHAGE (Study eye)	Eye disorders	Verteporfin + Ranibizumab	7	122
other	RETINAL HAEMORRHAGE (Study eye)	Eye disorders	Ranibizumab	5	133

1 to 10 of 182Source ClinicalTrials.gov

See all 182 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Verteporfin + Ranibizumab
Total, all-cause mortality	Ranibizumab
Total, other adverse events	Verteporfin + Ranibizumab	64	122
Total, other adverse events	Ranibizumab	63	133
Total, serious adverse events	Verteporfin + Ranibizumab	25	122
Total, serious adverse events	Ranibizumab	28	133

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
22424834	DERIVED	PubMed
25079064	DERIVED	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 comparisons1

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

Comparison
Verteporfin + Ranibizumab vs Ranibizumab: 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/NCT00433017

GET https://conductscience.org/api/trials/v1/NCT00433017/results?page=2

API reference For AI assistants