Trial · NCT01884597
Investigator Sponsored Trial of Polypoidal Choroidal Vasculopathy (PCV) Evaluation Assessing High-Dose Ranibizumab Prospectively (PEARL2)
NCT01884597, Phase 1, Phase 2, Completed, Hawaii Pacific Health; results first posted 2017-09-11
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Investigator Sponsored Trial of Polypoidal Choroidal Vasculopathy (PCV) Evaluation Assessing High-Dose Ranibizumab Prospectively (PEARL2). Trials, record NCT01884597. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01884597
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Investigator Sponsored Trial of Polypoidal Choroidal Vasculopathy (PCV) Evaluation Assessing High-Dose Ranibizumab Prospectively (PEARL2)
- NCT number
- NCT01884597
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 24 participants, actual
- Lead sponsor
- Hawaii Pacific Health
- Conditions
- PCV, Polypoidal Choroidal Vasculopathy
- Interventions
- high-dose ranibizumab, ranibizumab
- First posted
- 2013-06-24
- Last updated
- 2017-10-09
- Results first posted
- 2017-09-11
- Limitations and caveats
- Small sample size for each arms group.
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | BCVA | From Baseline to Month 12 | Mean change in best corrected visual acuity (BCVA), as assessed by the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) eye chart at a starting test distance of 4 meters from Baseline to Month 12. |
| Primary | BCVA | Baseline to M24 | Mean change in best corrected visual acuity (BCVA), as assessed by the number of letters read correctly on the ETDRS eye chart at a starting test distance of 4 meters from Baseline to Month 24 |
| Secondary | Ocular Adverse Events (AE) | Monthly | Incidence and severity of ocular adverse events, as identified by eye examination (including visual acuity testing) |
| Secondary | Systemic AEs | Monthly | Incidence and severity of other adverse events, as identified by physical examination, subject reporting, and changes in vital signs |
| Secondary | BCVA | at Baseline, Day 14, Month 1, Month 3, Month 6, Month 9 , Month 12, Month 15, Month 18, Month 21 and Month 24 | Best corrected visual acuity (BCVA), as assessed by the number of letters read correctly on the ETDRS eye chart at a starting test distance of 4 meters, at Baseline, Day 14, Month 1, Month 3, Month 6, Month 9 , Month 12, Month 15, Month 18, Month 21 and Month 24 |
| Secondary | Macular Edema | Baseline, Day 14, Month 1-24 | Optical Coherence Tomography (OCT) central macular and peripapillary thickness |
| Secondary | PCV Anatomic Changes | Baseline, Months 6, 12, 24 | Decrease and/or resolution in the branching vascular network of the PCV complex as measured by mean size of the branched vascular network (BVN) on ICG and fluorescein angiography Decrease and/or resolution of the polyps of the PCV complex as measured on ICG and fluorescein angiography |
| Secondary | Fundus Clinical Findings | Baseline, Months 6, 12, 24 | Decrease in subretinal hemorrhage or exudates as measured by mean size as noted on fundus photography and clinic exam |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | BCVA | From Baseline to Month 12 | number of letters read correctly | MEAN | |
| PRIMARY | BCVA | Baseline to M24 | number of letters read correctly | MEAN | |
| SECONDARY | Ocular Adverse Events (AE) | Monthly | Ocular adverse events | NUMBER | |
| SECONDARY | Systemic AEs | Monthly | Number of Participants with Systemic AEs | NUMBER | |
| SECONDARY | BCVA | at Baseline, Day 14, Month 1, Month 3, Month 6, Month 9 , Month 12, Month 15, Month 18, Month 21 and Month 24 | number of letters read correctly | MEAN | |
| SECONDARY | Macular Edema | Baseline, Day 14, Month 1-24 | Patient in Cohort 2 missed several visits. | microns | MEAN |
| SECONDARY | PCV Anatomic Changes | Baseline, Months 6, 12, 24 | Participants with PCV Anatomic Changes | NUMBER | |
| SECONDARY | Fundus Clinical Findings | Baseline, Months 6, 12, 24 | Participants with Fundus Findings | NUMBER |
Source ClinicalTrials.gov
Results by group159
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| BCVA | Cohort 1 | -3.50 | Standard Deviation 21.52 | number of letters read correctly | |
| BCVA | Cohort 2 | 29.50 | Standard Deviation 24.75 | number of letters read correctly | |
| BCVA | Cohort 3 | 8.60 | Standard Deviation 12.57 | number of letters read correctly | |
| BCVA | Cohort 1 | -5.75 | Standard Deviation 24.58 | number of letters read correctly | |
| BCVA | Cohort 2 | 23.5 | Standard Deviation 44.54 | number of letters read correctly | |
| BCVA | Cohort 3 | 5.13 | Standard Deviation 15.98 | number of letters read correctly | |
| Ocular Adverse Events (AE) | Cohort 1 | 0 | Ocular adverse events | ||
| Ocular Adverse Events (AE) | Cohort 2 | 0 | Ocular adverse events | ||
| Ocular Adverse Events (AE) | Cohort 3 | 0 | Ocular adverse events | ||
| Systemic AEs | Cohort 1 | 0 | Number of Participants with Systemic AEs |
1 to 10 of 159Source ClinicalTrials.gov
See all 159 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort 1 | 5 | |
| Overall Study | STARTED | Cohort 2 | 3 | |
| Overall Study | STARTED | Cohort 3 | 16 | |
| Overall Study | COMPLETED | Cohort 1 | 4 | |
| Overall Study | COMPLETED | Cohort 2 | 2 | |
| Overall Study | COMPLETED | Cohort 3 | 15 | |
| Overall Study | NOT COMPLETED | Cohort 1 | 1 | |
| Overall Study | NOT COMPLETED | Cohort 2 | 1 | |
| Overall Study | NOT COMPLETED | Cohort 3 | 1 |
Source ClinicalTrials.gov
Adverse events30
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 | Flu-like symptoms | General disorders | Cohort 1 | 0 | 4 | 0 |
| other | Flu-like symptoms | General disorders | Cohort 2 | 0 | 3 | 0 |
| other | Flu-like symptoms | General disorders | Cohort 3 | 1 | 15 | 1 |
| other | Rash | General disorders | Cohort 1 | 0 | 4 | 0 |
| other | Rash | General disorders | Cohort 2 | 0 | 3 | 0 |
| other | Rash | General disorders | Cohort 3 | 1 | 15 | 2 |
| other | Ear Infection | Infections and infestations | Cohort 1 | 0 | 4 | 0 |
| other | Ear Infection | Infections and infestations | Cohort 2 | 0 | 3 | 0 |
| other | Ear Infection | Infections and infestations | Cohort 3 | 1 | 15 | 1 |
| other | Body ache, fever, hives | General disorders | Cohort 1 | 0 | 4 | 0 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1 | ||
| Total, all-cause mortality | Cohort 2 | ||
| Total, all-cause mortality | Cohort 3 | ||
| Total, other adverse events | Cohort 1 | 1 | 4 |
| Total, other adverse events | Cohort 2 | 1 | 3 |
| Total, other adverse events | Cohort 3 | 7 | 15 |
| Total, serious adverse events | Cohort 1 | 1 | 4 |
| Total, serious adverse events | Cohort 2 | 0 | 2 |
| Total, serious adverse events | Cohort 3 | 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 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/NCT01884597
GET https://conductscience.org/api/trials/v1/NCT01884597/results?page=2