Trial · NCT02222610
Study of the Efficacy and Tolerability of Intravitreal Injections of Ranibizumab Compared to Intravitreal Injections of Ranibizumab Combined With Targeted Retinal Photocoagulation to Treat Radiation Retinopathy.
NCT02222610, Phase 2, Completed, Greater Houston Retina Research; results first posted 2021-03-25
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of the Efficacy and Tolerability of Intravitreal Injections of Ranibizumab Compared to Intravitreal Injections of Ranibizumab Combined With Targeted Retinal Photocoagulation to Treat Radiation Retinopathy. Trials, record NCT02222610. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02222610
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Study of the Efficacy and Tolerability of Intravitreal Injections of Ranibizumab Compared to Intravitreal Injections of Ranibizumab Combined With Targeted Retinal Photocoagulation to Treat Radiation Retinopathy.
- NCT number
- NCT02222610
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 40 participants, actual
- Lead sponsor
- Greater Houston Retina Research
- Conditions
- Radiation Retinopathy
- Interventions
- 0.5 mg ranibizumab, Targeted Retinal Photocoagulation (TRP)
- First posted
- 2014-08-21
- Last updated
- 2021-03-25
- Results first posted
- 2021-03-25
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Change in Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity at 104 Weeks From Day 0. | 104 weeks | Early Treatment Diabetic Retinopathy Study (ETDRS) Best-Corrected Visual Acuity (BCVA) utilizes the ETDRS visual acuity chart to measure vision in clinical trials. Standard unit of measure is the number of letters subjects are able to read on the chart. |
| Secondary | The Mean Number of Intravitreal Injections Required Per Subject Per Cohort. | 104 weeks | |
| Secondary | Percentage of Subjects With Retinal Hemorrhage at 104 Weeks. | 104 weeks | |
| Secondary | Percentage of Subjects With Intraretinal Exudates on Fundus Examination at Week 104. | 104 weeks | |
| Secondary | Mean Change in Central Mean Thickness According to Spectral-domain Optical Coherence Tomography at Week 104 Compared to Baseline. | 104 weeks | Spectral-domain optical coherence tomography (SD-OCT) is a common imaging modality used to visualize the layers of the macula. Central mean thickness (CMT) is the length in microns from the internal limiting membrane to Bruch's membrane. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Change in Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity at 104 Weeks From Day 0. | 104 weeks | Subjects analyzed only include those that completed the W104 visit. | letters | MEAN |
| SECONDARY | The Mean Number of Intravitreal Injections Required Per Subject Per Cohort. | 104 weeks | injections | MEAN | |
| SECONDARY | Percentage of Subjects With Retinal Hemorrhage at 104 Weeks. | 104 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Percentage of Subjects With Intraretinal Exudates on Fundus Examination at Week 104. | 104 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Mean Change in Central Mean Thickness According to Spectral-domain Optical Coherence Tomography at Week 104 Compared to Baseline. | 104 weeks | micrometers | MEAN |
Source ClinicalTrials.gov
Results by group15
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Change in Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity at 104 Weeks From Day 0. | Cohort A | -1.9 | Standard Deviation 7.4 | letters | |
| Mean Change in Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity at 104 Weeks From Day 0. | Cohort B | -3.9 | Standard Deviation 16.5 | letters | |
| Mean Change in Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity at 104 Weeks From Day 0. | Cohort C | 1.3 | Standard Deviation 11.8 | letters | |
| The Mean Number of Intravitreal Injections Required Per Subject Per Cohort. | Cohort A | 22.2 | Full Range 19 to 25 | injections | |
| The Mean Number of Intravitreal Injections Required Per Subject Per Cohort. | Cohort B | 18.5 | Full Range 11 to 25 | injections | |
| The Mean Number of Intravitreal Injections Required Per Subject Per Cohort. | Cohort C | 16.1 | Full Range 6 to 26 | injections | |
| Percentage of Subjects With Retinal Hemorrhage at 104 Weeks. | Cohort A | 1 | Participants | ||
| Percentage of Subjects With Retinal Hemorrhage at 104 Weeks. | Cohort B | 0 | Participants | ||
| Percentage of Subjects With Retinal Hemorrhage at 104 Weeks. | Cohort C | 3 | Participants | ||
| Percentage of Subjects With Intraretinal Exudates on Fundus Examination at Week 104. | Cohort A | 1 | Participants |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Baseline to W48 | STARTED | Cohort A | 8 | 8 |
| Baseline to W48 | STARTED | Cohort B | 16 | 16 |
| Baseline to W48 | STARTED | Cohort C | 16 | 16 |
| Baseline to W48 | COMPLETED | Cohort A | 8 | 8 |
| Baseline to W48 | COMPLETED | Cohort B | 14 | 14 |
| Baseline to W48 | COMPLETED | Cohort C | 15 | 15 |
| Baseline to W48 | NOT COMPLETED | Cohort A | 0 | 0 |
| Baseline to W48 | NOT COMPLETED | Cohort B | 2 | 2 |
| Baseline to W48 | NOT COMPLETED | Cohort C | 1 | 1 |
| Baseline to W104 | STARTED | Cohort A | 8 | 8 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events54
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 | Corneal Abrasion | Eye disorders | Cohort A | 0 | 8 | 0 |
| other | Corneal Abrasion | Eye disorders | Cohort B | 0 | 16 | 0 |
| other | Corneal Abrasion | Eye disorders | Cohort C | 1 | 16 | 1 |
| other | Dry Eyes | Eye disorders | Cohort A | 0 | 8 | 0 |
| other | Dry Eyes | Eye disorders | Cohort B | 0 | 16 | 0 |
| other | Dry Eyes | Eye disorders | Cohort C | 1 | 16 | 1 |
| other | Increased Cup-to-Disc Rratio | Eye disorders | Cohort A | 0 | 8 | 0 |
| other | Increased Cup-to-Disc Rratio | Eye disorders | Cohort B | 2 | 16 | 2 |
| other | Increased Cup-to-Disc Rratio | Eye disorders | Cohort C | 0 | 16 | 0 |
| other | Ocular Irritation | Eye disorders | Cohort A | 0 | 8 | 0 |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort A | 0 | 8 |
| Total, all-cause mortality | Cohort B | 0 | 16 |
| Total, all-cause mortality | Cohort C | 1 | 16 |
| Total, other adverse events | Cohort A | 3 | 8 |
| Total, other adverse events | Cohort B | 7 | 16 |
| Total, other adverse events | Cohort C | 6 | 16 |
| Total, serious adverse events | Cohort A | 1 | 8 |
| Total, serious adverse events | Cohort B | 2 | 16 |
| Total, serious adverse events | Cohort C | 5 | 16 |
Source ClinicalTrials.gov
Papers21
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/NCT02222610
GET https://conductscience.org/api/trials/v1/NCT02222610/events?page=2