Trial · NCT01495208
Open Label to Study to Evaluate Effect of Alfilbercept on Patients With (FVPED) Fibrovascular Pigment Epithelial Detachment
NCT01495208, Phase 4, Withdrawn, Vitreous -Retina- Macula Consultants of New York
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Open Label to Study to Evaluate Effect of Alfilbercept on Patients With (FVPED) Fibrovascular Pigment Epithelial Detachment. Trials, record NCT01495208. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01495208
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Open Label to Study to Evaluate Effect of Alfilbercept on Patients With (FVPED) Fibrovascular Pigment Epithelial Detachment
- NCT number
- NCT01495208
- Status
- Withdrawn
- Phases
- Phase 4
- Enrollment
- 0 participants, actual
- Lead sponsor
- Vitreous -Retina- Macula Consultants of New York
- Conditions
- Fibrovascular Pigment Epithelial Detachment
- Interventions
- Aflibercept
- First posted
- 2011-12-19
- Last updated
- 2018-07-16
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in retinal anatomy (size of FVPED, sub-retinal fluid and retinal volume) from baseline; measured using Spectralis OCT (Heidelberg Engineering, Germany) | 24 weeks is the primary end point of the study | Using the Heidelberg software, subfoveal subretinal fluid (distance between the IS/OS line and the RPE line on SDOCT) |
| Primary | Change in retinal anatomy (size of FVPED, sub-retinal fluid and retinal volume) from baseline; measured using Spectralis OCT (Heidelberg Engineering, Germany) | 24 weeks is the primary end point of the study | Measure of retinal volume (distance between the ILM and RPE outer margin on SDOCT) |
| Primary | Change in retinal anatomy (size of FVPED, sub-retinal fluid and retinal volume) from baseline; measured using Spectralis OCT (Heidelberg Engineering, Germany) | 24 weeks is the primary end point of the study | Measure of PED height (distance between ILM and Bruchs membrane (if visible) or the horizontal line where the RPE should be present if it was not elevated) |
| Primary | Change in retinal anatomy (size of FVPED, sub-retinal fluid and retinal volume) from baseline; measured using Spectralis OCT (Heidelberg Engineering, Germany) | 24 weeks is the primary end point of the study | Measure of maximal diameter of the PED (measured as the point from where the RPE detachment begins to where it ends) will be measured. |
| Secondary | Mean change in best corrected visual acuity (BCVA) from baseline; measured by ETDRS visual refraction at 4 meters. | 24 weeks is the primary end point of the study | * Proportion of patients losing ≤ 15 ETDRS letters compared to baseline. * Proportion of patients gaining ≥ 5 ETDRS letters compared to baseline. |
| Secondary | Mean change in best corrected visual acuity (BCVA) from baseline; measured by ETDRS | 24 weeks is the primary end point of the study | Measure the Change in sub-RPE tissue characteristics from baseline; determined using EDI-OCT on the Spectralis OCT |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
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 totals0
The totals the trial posted for each group.
None in this release.
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 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.
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/NCT01495208
GET https://conductscience.org/api/trials/v1/NCT01495208/registered