Trial · NCT02863354
Intravitreal Aflibercept for Retinal Non-Perfusion in Proliferative Diabetic Retinopathy
NCT02863354, Phase 2, Completed, Charles C Wykoff, PhD, MD; results first posted 2021-04-21
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Intravitreal Aflibercept for Retinal Non-Perfusion in Proliferative Diabetic Retinopathy. Trials, record NCT02863354. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02863354
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Intravitreal Aflibercept for Retinal Non-Perfusion in Proliferative Diabetic Retinopathy
- NCT number
- NCT02863354
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 43 participants, actual
- Lead sponsor
- Charles C Wykoff, PhD, MD
- Conditions
- Proliferative Diabetic Retinopathy
- Interventions
- Aflibercept
- First posted
- 2016-08-11
- Last updated
- 2021-05-24
- Results first posted
- 2021-04-21
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 | 52 and 100 weeks | • Assess the safety and tolerability of IAI for the treatment of proliferative diabetic retinopathy by evaluating the incidence and severity of ocular and systemic adverse events through week 52 and week 100. |
| Secondary | Change in Early Treatment of Diabetic Retinopathy Severity Best Corrected Visual Acuity | 52 weeks and 100 weeks | Mean change in Early Treatment of Diabetic Retinopathy Study Best Corrected Visual Acuity (ETDRS-BCVA) from baseline to week 52 and week 100. |
| Secondary | Change in Area of Retinal Capillary Non-perfusion Within the Macula | 52 weeks and 100 weeks | Change in area of retinal capillary non-perfusion within the macula compared to baseline, as assessed by ultrawide-field fluorescein angiogram from baseline to week 52 and week 100. |
| Secondary | Change in Area of Retinal Capillary Non-perfusion Outside of the Macula | 52 weeks and 100 weeks | Change in area of retinal capillary non-perfusion outside of the macula from baseline to week 52 and week 100. |
| Secondary | Percentage of Subjects With Neovascularization Regression | 52 Weeks and 100 Weeks | Percentage of subjects with neovascularization regression (reduced area of neovascularization) as measured by the central image reading center from baseline to week 52 and week 100. |
| Secondary | Percentage of Subjects With Increased Neovascularization | 52 Weeks and 100 Weeks | Percentage of subjects with increased neovascularization from baseline to week 52 and week 100. |
| Secondary | Percentage of Subjects Who Develop Vitreous Hemorrhage | 52 Weeks and 100 Weeks | Percentage of subjects who develop vitreous hemorrhage from baseline to week 52 and week 100. |
| Secondary | Percentage of Subjects Treated With Pan-retinal Photocoagulation or Vitrectomy | 52 Weeks and 100 Weeks | Percentage of subjects treated with PRP or vitrectomy for progression of PDR from baseline to week 52 and week 100. |
| Secondary | Percentage of Subjects Who Develop Center-involving Diabetic Macular Edema | 52 Weeks and 100 Weeks | Percentage of subjects, at week 52 and week 100, who develop center-involving diabetic macular edema who did not have center-involving diabetic macular edema at baseline |
| Secondary | Changes in Visual Function Outcomes (Self Reported Visual Function) | 52 weeks and 100 weeks | Changes in self reported visual function utilizing the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) from baseline to week 52 and week 100. The NEI VFQ is a validated measure of patient-reported visual function measured on a scale from 0 (worst function) to 100 (best function). |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 | 52 and 100 weeks | 3 participants that were enrolled dropped out before their Week 4 visit and were replaced in the study. Thus, only 40 subjects of the original 43 were followed and analyzed in the study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change in Early Treatment of Diabetic Retinopathy Severity Best Corrected Visual Acuity | 52 weeks and 100 weeks | 3 participants that were enrolled dropped out before their Week 4 visit and were replaced in the study. Thus, only 40 subjects of the original 43 were followed and analyzed in the study.~Number analyzed at Week 52 and Week 100 differs from overall number analyzed due to lost to follow up or deceased participants. | ETDRS letters | MEAN |
| SECONDARY | Change in Area of Retinal Capillary Non-perfusion Within the Macula | 52 weeks and 100 weeks | 3 participants that were enrolled dropped out before their Week 4 visit and were replaced in the study. Thus, only 40 subjects of the original 43 were followed and analyzed in the study.~Number analyzed at Week 52 and Week 100 differs from overall number analyzed due to inability to analyze images, lost to follow up, or deceased participants. | mm^2 | MEAN |
| SECONDARY | Change in Area of Retinal Capillary Non-perfusion Outside of the Macula | 52 weeks and 100 weeks | 3 participants that were enrolled dropped out before their Week 4 visit and were replaced in the study. Thus, only 40 subjects of the original 43 were followed and analyzed in the study.~Number analyzed at Week 52 and Week 100 differs from overall number analyzed due to inability to analyze images, lost to follow up, or deceased participants. | mm^2 | MEAN |
| SECONDARY | Percentage of Subjects With Neovascularization Regression | 52 Weeks and 100 Weeks | 3 participants that were enrolled dropped out before their Week 4 visit and were replaced in the study. Thus, only 40 subjects of the original 43 were followed and analyzed in the study.~Number analyzed at Week 52 and Week 100 differs from overall number analyzed due to inability to analyze images, lost to follow up, or deceased participants. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Subjects With Increased Neovascularization | 52 Weeks and 100 Weeks | 3 participants that were enrolled dropped out before their Week 4 visit and were replaced in the study. Thus, only 40 subjects of the original 43 were followed and analyzed in the study.~Number analyzed at Week 52 and Week 100 differs from overall number analyzed due to inability to analyze images, lost to follow up, or deceased participants. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Subjects Who Develop Vitreous Hemorrhage | 52 Weeks and 100 Weeks | 3 participants that were enrolled dropped out before their Week 4 visit and were replaced in the study. Thus, only 40 subjects of the original 43 were followed and analyzed in the study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Subjects Treated With Pan-retinal Photocoagulation or Vitrectomy | 52 Weeks and 100 Weeks | 3 participants that were enrolled dropped out before their Week 4 visit and were replaced in the study. Thus, only 40 subjects of the original 43 were followed and analyzed in the study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Subjects Who Develop Center-involving Diabetic Macular Edema | 52 Weeks and 100 Weeks | 3 participants that were enrolled dropped out before their Week 4 visit and were replaced in the study. Thus, only 40 subjects of the original 43 were followed and analyzed in the study.~Number analyzed at Week 52 and Week 100 differs from overall number analyzed due to inability to analyze images, lost to follow up, or deceased participants. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Changes in Visual Function Outcomes (Self Reported Visual Function) | 52 weeks and 100 weeks | 3 participants that were enrolled dropped out before their Week 4 visit and were replaced in the study. Thus, only 40 subjects of the original 43 were followed and analyzed in the study.~Number analyzed at Week 52 and Week 100 differs from overall number analyzed due to inability to analyze images, lost to follow up, or deceased participants. | units on a scale | MEAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group48
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 | Q4WKS | Week 52 | 0 | Participants | |
| Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 | Q12WKS | Week 52 | 0 | Participants | |
| Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 | Q4WKS | Week 100 | 0 | Participants | |
| Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 | Q12WKS | Week 100 | 0 | Participants | |
| Change in Early Treatment of Diabetic Retinopathy Severity Best Corrected Visual Acuity | Q4WKS | Week 52 | 4.26 | 95% Confidence Interval 0.76 to 7.76 | ETDRS letters |
| Change in Early Treatment of Diabetic Retinopathy Severity Best Corrected Visual Acuity | Q12WKS | Week 52 | 4.53 | 95% Confidence Interval 1.83 to 7.23 | ETDRS letters |
| Change in Early Treatment of Diabetic Retinopathy Severity Best Corrected Visual Acuity | Q4WKS | Week 100 | 4.06 | 95% Confidence Interval -0.91 to 9.03 | ETDRS letters |
| Change in Early Treatment of Diabetic Retinopathy Severity Best Corrected Visual Acuity | Q12WKS | Week 100 | 8.88 | 95% Confidence Interval 4.66 to 13.09 | ETDRS letters |
| Change in Area of Retinal Capillary Non-perfusion Within the Macula | Q4WKS | Week 52 | 0.048 | Standard Deviation 0.450 | mm^2 |
| Change in Area of Retinal Capillary Non-perfusion Within the Macula | Q12WKS | Week 52 | 0.217 | Standard Deviation 0.388 | mm^2 |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Year 1 | STARTED | Q4WKS | 23 | 23 |
| Year 1 | STARTED | Q12WKS | 20 | 20 |
| Year 1 | COMPLETED | Q4WKS | 19 | 19 |
| Year 1 | COMPLETED | Q12WKS | 18 | 18 |
| Year 1 | NOT COMPLETED | Q4WKS | 4 | 4 |
| Year 1 | NOT COMPLETED | Q12WKS | 2 | 2 |
| Year 2 | STARTED | Q4WKS | 19 | 19 |
| Year 2 | STARTED | Q12WKS | 18 | 18 |
| Year 2 | COMPLETED | Q4WKS | 17 | 17 |
| Year 2 | COMPLETED | Q12WKS | 16 | 16 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events36
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 | Worsening Cataract | Eye disorders | Q4WKS | 2 | 20 | 2 |
| other | Worsening Cataract | Eye disorders | Q12WKS | 4 | 20 | 4 |
| other | Subconjunctival Hemorrhage | Eye disorders | Q4WKS | 4 | 20 | 4 |
| other | Subconjunctival Hemorrhage | Eye disorders | Q12WKS | 0 | 20 | 0 |
| other | Vitreous Hemorrhage | Eye disorders | Q4WKS | 2 | 20 | 2 |
| other | Vitreous Hemorrhage | Eye disorders | Q12WKS | 1 | 20 | 1 |
| other | Floater | Ear and labyrinth disorders | Q4WKS | 2 | 20 | 2 |
| other | Floater | Ear and labyrinth disorders | Q12WKS | 1 | 20 | 1 |
| other | Photophobia | Eye disorders | Q4WKS | 2 | 20 | 2 |
| other | Photophobia | Eye disorders | Q12WKS | 0 | 20 | 0 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Q4WKS | 0 | 20 |
| Total, all-cause mortality | Q12WKS | 1 | 20 |
| Total, other adverse events | Q4WKS | 9 | 20 |
| Total, other adverse events | Q12WKS | 8 | 20 |
| Total, serious adverse events | Q4WKS | 2 | 20 |
| Total, serious adverse events | Q12WKS | 2 | 20 |
Source ClinicalTrials.gov
Papers15
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Q4WKS vs Q12WKS: deaths from any cause | Trial comparisons |
| Q4WKS vs Q12WKS: 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/NCT02863354
GET https://conductscience.org/api/trials/v1/NCT02863354/results?page=2