Trial · NCT01489189
Prompt Panretinal Photocoagulation Versus Ranibizumab+Deferred Panretinal Photocoagulation for Proliferative Diabetic Retinopathy
NCT01489189, Phase 3, Completed, Jaeb Center for Health Research; results first posted 2016-06-01
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Prompt Panretinal Photocoagulation Versus Ranibizumab+Deferred Panretinal Photocoagulation for Proliferative Diabetic Retinopathy. Trials, record NCT01489189. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01489189
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Prompt Panretinal Photocoagulation Versus Ranibizumab+Deferred Panretinal Photocoagulation for Proliferative Diabetic Retinopathy
- NCT number
- NCT01489189
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 305 participants, actual
- Lead sponsor
- Jaeb Center for Health Research
- Conditions
- Proliferative Diabetic Retinopathy
- Interventions
- Prompt Panretinal Photocoagulation, 0.5-mg Ranibizumab, Deferred panretinal photocoagulation
- First posted
- 2011-12-09
- Last updated
- 2021-10-29
- Results first posted
- 2016-06-01
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Change in Visual Acuity From Baseline | 2-years | Visual acuity is measured as a continuous integer letter score from 0 to 100, with higher numbers indicating better visual acuity. A letter score of 85 is approximately 20/20 and a letter score of 70 is approximately 20/40, the legal unrestricted driving limit in most states. A 5-letter change for an individual is approximately equal to a 1-line change on a vision chart. |
| Secondary | Mean Visual Acuity | 2-years | Visual acuity is measured as a continuous integer letter score from 0 to 100, with higher numbers indicating better visual acuity. A letter score of 85 is approximately 20/20 and a letter score of 70 is approximately 20/40, the legal unrestricted driving limit in most states. A 5-letter change for an individual is approximately equal to a 1-line change on a vision chart. |
| Secondary | Number of Eyes With Greater Than or Equal to 10 Letter Vision Gain | 2-years | |
| Secondary | Humphrey Visual Field Test Cumulative Score Change From Baseline | 2-years | Visual fields, collected using the Humphrey Visual Field analyzer, measured the total point score (sum of retinal sensitivities of all points) tested on 30-2 and 60-4 patterns, which included the mid-peripheral and peripheral visual fields. A lower score indicates greater visual field loss.The cumulative score is the sum of all visual field sensitivity values for each of the four individual quadrants of the visual field (the quadrants are divided by the horizontal and vertical lines). The range can be from 0 to about 600 for the 30-2 test \[for each quadrant\], and from 0 to about 400 or 450 for the peripheral test. |
| Secondary | Frequency of Vitrectomy | 2-years | |
| Secondary | Mean Change in OCT Central Subfield Thickness From Baseline | 2-years | All baseline and 2-year optical coherence tomography (OCT) scans were evaluated by the OCT reading center. |
| Secondary | Development of Central DME With Vision Impairment by 2-years | 2-years | |
| Secondary | Number of Eyes With Vitreous Hemorrhage | 2-years | |
| Secondary | Number of Eyes Without Active or Regressed Neovascularization on Fundus Photography at 2-years | 2-years | |
| Secondary | Number of Eyes With Greater Than or Equal to 10 Letter Vision Loss | 2-year |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Change in Visual Acuity From Baseline | 2-years | Participants that completed the 2-year visit. | letters | MEAN |
| SECONDARY | Mean Visual Acuity | 2-years | Participants that completed the 2-year visit. | letters | MEAN |
| SECONDARY | Number of Eyes With Greater Than or Equal to 10 Letter Vision Gain | 2-years | Eyes with a baseline letter score of 78 or less (approximate Snellen equivalent 20/32 or worse) from participants that completed the 2-year visit. | eyes | NUMBER |
| SECONDARY | Humphrey Visual Field Test Cumulative Score Change From Baseline | 2-years | Humphrey visual fields were obtained at a subset of sites. Fields with excessive false positive response, excessive false negative response, or excessive fixation loss were excluded from analysis. Twenty-two eyes in the anti-VEGF+deferred PRP group and 25 eyes in the prompt PRP group were excluded. | decibels | MEDIAN |
| SECONDARY | Frequency of Vitrectomy | 2-years | eyes | NUMBER | |
| SECONDARY | Mean Change in OCT Central Subfield Thickness From Baseline | 2-years | Eyes with optical coherence tomography (OCT) data at baseline and 2-years. | µm | MEAN |
| SECONDARY | Development of Central DME With Vision Impairment by 2-years | 2-years | Excludes that did not have central DME with vision impairment (20/32 or worse) at baseline. | eyes | NUMBER |
| SECONDARY | Number of Eyes With Vitreous Hemorrhage | 2-years | Eyes | NUMBER | |
| SECONDARY | Number of Eyes Without Active or Regressed Neovascularization on Fundus Photography at 2-years | 2-years | Eyes with baseline diabetic retinopathy level 61B or worse (active neovascularization). Last-observation-carried-forward was used for 23 eyes in the anti-VEGF+Deferred PRP group and 25 eyes in the Prompt PRP group missing photographs at 2 years if 1-year fundus photographs were available. | eyes | NUMBER |
| SECONDARY | Number of Eyes With Greater Than or Equal to 10 Letter Vision Loss | 2-year | Participants that completed the 2-year visit. | eyes | NUMBER |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Change in Visual Acuity From Baseline | Anti-VEGF+Deferred PRP | 2.8 | 95% Confidence Interval 0.4 to 5.2 | letters | |
| Mean Change in Visual Acuity From Baseline | Prompt PRP | 0.2 | 95% Confidence Interval -1.9 to 2.3 | letters | |
| Mean Visual Acuity | Anti-VEGF+Deferred PRP | 78.7 | Standard Deviation 16.3 | letters | |
| Mean Visual Acuity | Prompt PRP | 76.2 | Standard Deviation 14.1 | letters | |
| Number of Eyes With Greater Than or Equal to 10 Letter Vision Gain | Anti-VEGF+Deferred PRP | 35 | eyes | ||
| Number of Eyes With Greater Than or Equal to 10 Letter Vision Gain | Prompt PRP | 31 | eyes | ||
| Humphrey Visual Field Test Cumulative Score Change From Baseline | Anti-VEGF+Deferred PRP | -25 | Inter-Quartile Range -232 to 223 | decibels | |
| Humphrey Visual Field Test Cumulative Score Change From Baseline | Prompt PRP | -379 | Inter-Quartile Range -723 to -75 | decibels | |
| Frequency of Vitrectomy | Anti-VEGF+Deferred PRP | 8 | eyes | ||
| Frequency of Vitrectomy | Prompt PRP | 30 | eyes |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Anti-VEGF+Deferred PRP | 191 | |
| Overall Study | STARTED | Prompt PRP | 203 | |
| Overall Study | COMPLETED | Anti-VEGF+Deferred PRP | 160 | |
| Overall Study | COMPLETED | Prompt PRP | 168 | |
| Overall Study | NOT COMPLETED | Anti-VEGF+Deferred PRP | 31 | |
| Overall Study | NOT COMPLETED | Prompt PRP | 35 |
Source ClinicalTrials.gov
Adverse events1,590
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 | Anaemia | Blood and lymphatic system disorders | Bilateral Participants | 7 | 89 | |
| other | Anaemia | Blood and lymphatic system disorders | Anti-VEGF+Deferred PRP | 9 | 102 | |
| other | Anaemia | Blood and lymphatic system disorders | Prompt PRP | 6 | 114 | |
| other | Anaemia of chronic disease | Blood and lymphatic system disorders | Bilateral Participants | 2 | 89 | |
| other | Anaemia of chronic disease | Blood and lymphatic system disorders | Anti-VEGF+Deferred PRP | 1 | 102 | |
| other | Anaemia of chronic disease | Blood and lymphatic system disorders | Prompt PRP | 0 | 114 | |
| other | Leukocytosis | Blood and lymphatic system disorders | Bilateral Participants | 1 | 89 | |
| other | Leukocytosis | Blood and lymphatic system disorders | Anti-VEGF+Deferred PRP | 0 | 102 | |
| other | Leukocytosis | Blood and lymphatic system disorders | Prompt PRP | 0 | 114 | |
| other | Lymphoedema | Blood and lymphatic system disorders | Bilateral Participants | 0 | 89 |
1 to 10 of 1,590Source ClinicalTrials.gov
See all 1,590 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Bilateral Participants | ||
| Total, all-cause mortality | Anti-VEGF+Deferred PRP | ||
| Total, all-cause mortality | Prompt PRP | ||
| Total, other adverse events | Bilateral Participants | 85 | 89 |
| Total, other adverse events | Anti-VEGF+Deferred PRP | 96 | 102 |
| Total, other adverse events | Prompt PRP | 105 | 114 |
| Total, serious adverse events | Bilateral Participants | 36 | 89 |
| Total, serious adverse events | Anti-VEGF+Deferred PRP | 50 | 102 |
| Total, serious adverse events | Prompt PRP | 43 | 114 |
Source ClinicalTrials.gov
Papers17
The papers the trial lists on ClinicalTrials.gov.
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/NCT01489189
GET https://conductscience.org/api/trials/v1/NCT01489189/events?page=2