Trial · NCT00527475
Ranibizumab and Reduced Fluence PDT for AMD
NCT00527475, Phase 2, Completed, Texas Retina Associates; results first posted 2013-06-07
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Ranibizumab and Reduced Fluence PDT for AMD. Trials, record NCT00527475. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00527475
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Ranibizumab and Reduced Fluence PDT for AMD
- NCT number
- NCT00527475
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 60 participants, actual
- Lead sponsor
- Texas Retina Associates
- Conditions
- Macular Degeneration
- Interventions
- ranibizumab, verteporfin
- First posted
- 2007-09-11
- Last updated
- 2025-11-28
- Results first posted
- 2013-06-07
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Percentage of Patients With Less Than 15 Letters of ETDRS Visual Loss at 12 Months. | 1 year | |
| Secondary | Percentage of Participants With Retreatments Over One Year | 1 year | Number of days to retreatment outcome changed to frequency of retreatments at maintenance visits. |
| Secondary | Number of Injections Over 12 Months | 1 year | Additional number of ranibizumab injections given in each group over the 12 months |
| Secondary | Percentage of Subjects Gaining More Than 15 ETDRS Letters of Acuity | 1 year | |
| Secondary | Improvement in OCT (Optical Coherent Tomography) Foveal Thickness at 12 Months | 1 year | Improvement in OCT (Optical coherent tomography) foveal thickness at 12 months/Number of microns in foveal thickness measurement |
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 | The Percentage of Patients With Less Than 15 Letters of ETDRS Visual Loss at 12 Months. | 1 year | Fifty-six participants completed the full 12 month study. Four subjects did not return for the 12 month visit. No patients terminated the study due to adverse events. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Retreatments Over One Year | 1 year | % of subjects requiring additional injec | NUMBER | |
| SECONDARY | Number of Injections Over 12 Months | 1 year | injections | MEAN | |
| SECONDARY | Percentage of Subjects Gaining More Than 15 ETDRS Letters of Acuity | 1 year | percentage | NUMBER | |
| SECONDARY | Improvement in OCT (Optical Coherent Tomography) Foveal Thickness at 12 Months | 1 year | microns | MEAN |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Percentage of Patients With Less Than 15 Letters of ETDRS Visual Loss at 12 Months. | Group I | 22 | percentage of participants | ||
| The Percentage of Patients With Less Than 15 Letters of ETDRS Visual Loss at 12 Months. | Group II | 14 | percentage of participants | ||
| Percentage of Participants With Retreatments Over One Year | Group I | 33 | % of subjects requiring additional injec | ||
| Percentage of Participants With Retreatments Over One Year | Group II | 21 | % of subjects requiring additional injec | ||
| Number of Injections Over 12 Months | Group I | 6.8 | Standard Deviation 2.49 | injections | |
| Number of Injections Over 12 Months | Group II | 3.0 | Standard Deviation 2.43 | injections | |
| Percentage of Subjects Gaining More Than 15 ETDRS Letters of Acuity | Group I | 33 | percentage | ||
| Percentage of Subjects Gaining More Than 15 ETDRS Letters of Acuity | Group II | 31 | percentage | ||
| Improvement in OCT (Optical Coherent Tomography) Foveal Thickness at 12 Months | Group I | 91.4 | Standard Deviation 12.8 | microns | |
| Improvement in OCT (Optical Coherent Tomography) Foveal Thickness at 12 Months | Group II | 104.1 | Standard Deviation 9.0 | microns |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ranibizumab | 30 | |
| Overall Study | STARTED | Reduced Fluence PDT & Ranibizumab | 30 | |
| Overall Study | COMPLETED | Ranibizumab | 27 | |
| Overall Study | COMPLETED | Reduced Fluence PDT & Ranibizumab | 29 | |
| Overall Study | NOT COMPLETED | Ranibizumab | 3 | |
| Overall Study | NOT COMPLETED | Reduced Fluence PDT & Ranibizumab | 1 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Group I | 0 | 30 |
| Total, all-cause mortality | Group II | 0 | 30 |
| Total, other adverse events | Group I | 0 | 30 |
| Total, other adverse events | Group II | 0 | 30 |
| Total, serious adverse events | Group I | 0 | 30 |
| Total, serious adverse events | Group II | 0 | 30 |
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 |
|---|---|
| Group I vs Group II: deaths from any cause | Trial comparisons |
| Group I vs Group II: serious adverse events | 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.
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/NCT00527475
GET https://conductscience.org/api/trials/v1/NCT00527475/registered