Trial · NCT01909791
Treatment for CI-DME in Eyes With Very Good VA Study
NCT01909791, Phase 3, Completed, Jaeb Center for Health Research; results first posted 2020-01-03
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Treatment for CI-DME in Eyes With Very Good VA Study. Trials, record NCT01909791. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01909791
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Treatment for CI-DME in Eyes With Very Good VA Study
- NCT number
- NCT01909791
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 702 participants, actual
- Lead sponsor
- Jaeb Center for Health Research
- Conditions
- Diabetic Macular Edema
- Interventions
- Prompt Laser, Prompt aflibercept, Deferred laser, Deferred aflibercept
- First posted
- 2013-07-29
- Last updated
- 2020-07-31
- Results first posted
- 2020-01-03
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Eyes With at Least 5-letter Decrease in E-ETDRS Visual Acuity Letter Score From Baseline | 2 years | Best-corrected visual acuity following protocol-defined refraction. Visual Acuity was measured with the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity test on a scale from 100 letters (Snellen equivalent of 20/12) to 0 letters (Snellen equivalent of 20/800). |
| Secondary | Number of Eyes With at Least 5-letter Increase or at Least 5-, 10-, or 15-letter Decrease in E-ETDRS Visual Acuity Letter Score From Baseline | 1 year | Best-corrected visual acuity following protocol-defined refraction. Visual Acuity was measured with the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity test on a scale from 100 letters (Snellen equivalent of 20/12) to 0 letters (Snellen equivalent of 20/800). |
| Secondary | Change in E-ETDRS Visual Acuity Letter Score From Baseline | 1 year | Best-corrected visual acuity following protocol-defined refraction. Visual Acuity was measured with the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity test on a scale from 100 letters (Snellen equivalent of 20/12) to 0 letters (Snellen equivalent of 20/800). |
| Secondary | Change in E-ETDRS Visual Acuity Letter Score From Baseline Over 2 Years (Area Under the Curve) | 2 year | Best-corrected visual acuity following protocol-defined refraction. Visual Acuity was measured with the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity test on a scale from 100 letters (Snellen equivalent of 20/12) to 0 letters (Snellen equivalent of 20/800). The area under the curve (units = letters·years) was divided by 2 years (units = years) to obtain an average change in letter score (units = letters) over the 2-year follow-up. |
| Secondary | Change in OCT Central Subfield Thickness From Baseline | 2 years | |
| Secondary | Number of Eyes With at Least 1 or 2 Logarithmic-step Central Subfield Thickness Improvement and Worsening | 1 year | Logarithmic transformation of optical coherence tomography central subfield thickness (CST) is calculated by taking the log base 10 of the ratio of the central subfield thickness divided by 200 and rounding to the nearest hundredth. The change is the change in the log values. |
| Secondary | Number of Eyes With no Center-involved Diabetic Macular Edema and at Least 10% Central Subfield Thickness Decrease | 1 year | Center-involved diabetic macular edema defined as follows by central subfield thickness according to optical coherence tomography machine and sex: Heidelberg Spectralis ≥ 305 µm in women and ≥ 320 µm in men, and Zeiss Cirrus ≥ 290 µm in women and ≥ 305 µm in men. |
| Secondary | Cumulative Number of Intraocular Injections of 2.0-mg Aflibercept Received Per Participant | 1 year | |
| Secondary | Number of Eyes With ≥ 2-step Worsening of Diabetic Retinopathy | 2 years | Includes eyes with baseline severity level of 75 (high-risk proliferative diabetic retinopathy) or less based on reading center grading of color fundus photographs using the Early Treatment Diabetic Retinopathy Study severity scale. |
| Secondary | For Eyes Randomized to Initial Laser Photocoagulation and Initial Observation Groups, the Percentage Receiving Aflibercept Treatment | 2 years |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Eyes With at Least 5-letter Decrease in E-ETDRS Visual Acuity Letter Score From Baseline | 2 years | Eyes | COUNT_OF_UNITS | |
| SECONDARY | Number of Eyes With at Least 5-letter Increase or at Least 5-, 10-, or 15-letter Decrease in E-ETDRS Visual Acuity Letter Score From Baseline | 1 year | Eyes | COUNT_OF_UNITS | |
| SECONDARY | Change in E-ETDRS Visual Acuity Letter Score From Baseline | 1 year | units on a scale | MEAN | |
| SECONDARY | Change in E-ETDRS Visual Acuity Letter Score From Baseline Over 2 Years (Area Under the Curve) | 2 year | Best-corrected visual acuity letter score as measured by a certified tester using an electronic visual acuity testing machine based on the early treatment diabetic retinopathy study method . Best value on the scale 100, worst 0. | units on a scale | MEAN |
| SECONDARY | Change in OCT Central Subfield Thickness From Baseline | 2 years | microns | MEAN | |
| SECONDARY | Number of Eyes With at Least 1 or 2 Logarithmic-step Central Subfield Thickness Improvement and Worsening | 1 year | Eyes | COUNT_OF_UNITS | |
| SECONDARY | Number of Eyes With no Center-involved Diabetic Macular Edema and at Least 10% Central Subfield Thickness Decrease | 1 year | Eyes | COUNT_OF_UNITS | |
| SECONDARY | Cumulative Number of Intraocular Injections of 2.0-mg Aflibercept Received Per Participant | 1 year | Injections | MEAN | |
| SECONDARY | Number of Eyes With ≥ 2-step Worsening of Diabetic Retinopathy | 2 years | Eyes | COUNT_OF_UNITS | |
| SECONDARY | For Eyes Randomized to Initial Laser Photocoagulation and Initial Observation Groups, the Percentage Receiving Aflibercept Treatment | 2 years | Eyes | COUNT_OF_UNITS |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 outcomesResults by group86
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Eyes With at Least 5-letter Decrease in E-ETDRS Visual Acuity Letter Score From Baseline | Initiation With Aflibercept | 33 | Eyes | ||
| Number of Eyes With at Least 5-letter Decrease in E-ETDRS Visual Acuity Letter Score From Baseline | Initiation With Laser Photocoagulation | 36 | Eyes | ||
| Number of Eyes With at Least 5-letter Decrease in E-ETDRS Visual Acuity Letter Score From Baseline | Initiation With Observation | 39 | Eyes | ||
| Number of Eyes With at Least 5-letter Increase or at Least 5-, 10-, or 15-letter Decrease in E-ETDRS Visual Acuity Letter Score From Baseline | Initiation With Aflibercept | ≥ 5-Letter Increase | 61 | Eyes | |
| Number of Eyes With at Least 5-letter Increase or at Least 5-, 10-, or 15-letter Decrease in E-ETDRS Visual Acuity Letter Score From Baseline | Initiation With Laser Photocoagulation | ≥ 5-Letter Increase | 44 | Eyes | |
| Number of Eyes With at Least 5-letter Increase or at Least 5-, 10-, or 15-letter Decrease in E-ETDRS Visual Acuity Letter Score From Baseline | Initiation With Observation | ≥ 5-Letter Increase | 33 | Eyes | |
| Number of Eyes With at Least 5-letter Increase or at Least 5-, 10-, or 15-letter Decrease in E-ETDRS Visual Acuity Letter Score From Baseline | Initiation With Aflibercept | ≥ 5-Letter Decrease | 19 | Eyes | |
| Number of Eyes With at Least 5-letter Increase or at Least 5-, 10-, or 15-letter Decrease in E-ETDRS Visual Acuity Letter Score From Baseline | Initiation With Laser Photocoagulation | ≥ 5-Letter Decrease | 36 | Eyes | |
| Number of Eyes With at Least 5-letter Increase or at Least 5-, 10-, or 15-letter Decrease in E-ETDRS Visual Acuity Letter Score From Baseline | Initiation With Observation | ≥ 5-Letter Decrease | 25 | Eyes | |
| Number of Eyes With at Least 5-letter Increase or at Least 5-, 10-, or 15-letter Decrease in E-ETDRS Visual Acuity Letter Score From Baseline | Initiation With Aflibercept | ≥ 10-Letter Decrease | 6 | Eyes |
1 to 10 of 86Source ClinicalTrials.gov
See all 86 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Initiation With Aflibercept | 226 | |
| Overall Study | STARTED | Initiation With Laser Photocoagulation | 240 | |
| Overall Study | STARTED | Initiation With Observation | 236 | |
| Overall Study | COMPLETED | Initiation With Aflibercept | 205 | |
| Overall Study | COMPLETED | Initiation With Laser Photocoagulation | 212 | |
| Overall Study | COMPLETED | Initiation With Observation | 208 | |
| Overall Study | NOT COMPLETED | Initiation With Aflibercept | 21 | |
| Overall Study | NOT COMPLETED | Initiation With Laser Photocoagulation | 28 | |
| Overall Study | NOT COMPLETED | Initiation With Observation | 28 |
Source ClinicalTrials.gov
Adverse events2,064
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 | Initiation With Laser Photocoagulation | 6 | 240 | 6 |
| other | Anaemia | Blood and lymphatic system disorders | Initiation With Observation | 9 | 236 | 9 |
| other | Anaemia | Blood and lymphatic system disorders | Initiation With Aflibercept | 4 | 226 | 4 |
| other | Anaemia of chronic disease | Blood and lymphatic system disorders | Initiation With Laser Photocoagulation | 1 | 240 | 1 |
| other | Anaemia of chronic disease | Blood and lymphatic system disorders | Initiation With Observation | 1 | 236 | 1 |
| other | Anaemia of chronic disease | Blood and lymphatic system disorders | Initiation With Aflibercept | 1 | 226 | 1 |
| other | Leukocytosis | Blood and lymphatic system disorders | Initiation With Laser Photocoagulation | 2 | 240 | 2 |
| other | Leukocytosis | Blood and lymphatic system disorders | Initiation With Observation | 1 | 236 | 1 |
| other | Leukocytosis | Blood and lymphatic system disorders | Initiation With Aflibercept | 1 | 226 | 1 |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Initiation With Laser Photocoagulation | 0 | 240 | 0 |
1 to 10 of 2,064Source ClinicalTrials.gov
See all 2,064 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Initiation With Laser Photocoagulation | 10 | 226 |
| Total, all-cause mortality | Initiation With Observation | 9 | 240 |
| Total, all-cause mortality | Initiation With Aflibercept | 5 | 236 |
| Total, other adverse events | Initiation With Laser Photocoagulation | 194 | 240 |
| Total, other adverse events | Initiation With Observation | 197 | 236 |
| Total, other adverse events | Initiation With Aflibercept | 185 | 226 |
| Total, serious adverse events | Initiation With Laser Photocoagulation | 64 | 240 |
| Total, serious adverse events | Initiation With Observation | 77 | 236 |
| Total, serious adverse events | Initiation With Aflibercept | 69 | 226 |
Source ClinicalTrials.gov
Papers2
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/NCT01909791
GET https://conductscience.org/api/trials/v1/NCT01909791/results?page=2