Trial · NCT01006538
Macular EpiRetinal Brachytherapy Versus Lucentis® Only Treatment (MERLOT)
NCT01006538, Phase 4, Completed, King's College Hospital NHS Trust; results first posted 2019-07-22
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Macular EpiRetinal Brachytherapy Versus Lucentis® Only Treatment (MERLOT). Trials, record NCT01006538. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01006538
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Macular EpiRetinal Brachytherapy Versus Lucentis® Only Treatment (MERLOT)
- NCT number
- NCT01006538
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 363 participants, actual
- Lead sponsor
- King's College Hospital NHS Trust
- Conditions
- Macular Degeneration
- Interventions
- Epimacular Brachytherapy, Ranibizumab
- First posted
- 2009-11-03
- Last updated
- 2020-12-07
- Other registries' IDs
- eudract:2009-012509-20
- Results first posted
- 2019-07-22
- Limitations and caveats
- Radiation-related microvascular retinal changes may occur beyond the 12 month reporting window (three years' follow up is planned)
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Change in Early Treatment for Diabetic Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) From Baseline to Month 12 | 12 months | Manifest refraction and BCVA measurements were performed according to the standard procedure originally developed for Early Treatment for Diabetic Retinopathy Study (ETDRS) and adapted for the Age Related Eye Disease Study (AREDS) protocol. Visual acuity testing was measured at a distance of 4 meters and, for subjects with sufficiently reduced vision, at 1 meter. The ETDRS charts consist of 14 lines, each comprising a series of 5 letters of equal difficulty, with standardized spacing between letters and rows (total 70 letters). Minimum is 0 (no letters read at 1 m) and maximum possible is 100 (70 letters read at 4 m + 30). If visual acuity is so poor that the subject cannot read any of the largest letters at 1 meter count fingers (CF), hand movements (HM) and light perception (PL) are tested. The mean change in ETDRS BCVA was calculated from baseline to month 12. |
| Primary | Mean Number of Re-treatment Injections of Lucentis® Per Patient, Per Year. | 12 months | |
| Secondary | Percentage of Subjects Losing < 15 ETDRS Letters | 12 months | Manifest refraction and BCVA measurements were performed according to the standard procedure originally developed for Early Treatment for Diabetic Retinopathy Study (ETDRS) and adapted for the Age Related Eye Disease Study (AREDS) protocol. Visual acuity testing was measured at a distance of 4 meters and, for subjects with sufficiently reduced vision, at 1 meter. The ETDRS charts consist of 14 lines, each comprising a series of 5 letters of equal difficulty, with standardized spacing between letters and rows (total 70 letters). Minimum is 0 (no letters read at 1 m) and maximum possible is 100 (70 letters read at 4 m + 30). If visual acuity is so poor that the subject cannot read any of the largest letters at 1 meter count fingers (CF), hand movements (HM) and light perception (PL) are tested. Participants with worsening in BCVA by less than 15 EDTRS letters at month 12 compared with baseline were considered for this outcome measure. |
| Secondary | Percentage of Subjects Gaining ≥ 0 ETDRS Letters | 12 months | Manifest refraction and BCVA measurements were performed according to the standard procedure originally developed for Early Treatment for Diabetic Retinopathy Study (ETDRS) and adapted for the Age Related Eye Disease Study (AREDS) protocol. Visual acuity testing was measured at a distance of 4 meters and, for subjects with sufficiently reduced vision, at 1 meter. The ETDRS charts consist of 14 lines, each comprising a series of 5 letters of equal difficulty, with standardized spacing between letters and rows (total 70 letters). Minimum is 0 (no letters read at 1 m) and maximum possible is 100 (70 letters read at 4 m + 30). If visual acuity is so poor that the subject cannot read any of the largest letters at 1 meter count fingers (CF), hand movements (HM) and light perception (PL) are tested. Participants with an improvement in BCVA by more than 0 EDTRS letters at month 12 compared with baseline were considered for this outcome measure. |
| Secondary | Percentage of Subjects Gaining ≥ 15 ETDRS Letters | 12 months | Manifest refraction and BCVA measurements were performed according to the standard procedure originally developed for Early Treatment for Diabetic Retinopathy Study (ETDRS) and adapted for the Age Related Eye Disease Study (AREDS) protocol. Visual acuity testing was measured at a distance of 4 meters and, for subjects with sufficiently reduced vision, at 1 meter. The ETDRS charts consist of 14 lines, each comprising a series of 5 letters of equal difficulty, with standardized spacing between letters and rows (total 70 letters). Minimum is 0 (no letters read at 1 m) and maximum possible is 100 (70 letters read at 4 m + 30). If visual acuity is so poor that the subject cannot read any of the largest letters at 1 meter count fingers (CF), hand movements (HM) and light perception (PL) are tested. Participants with an improvement in BCVA by more than 15 EDTRS letters at month 12 compared with baseline were considered for this outcome measure. |
| Secondary | Change in Total Lesion Size by Fluorescein Angiography From Baseline to Month 12 | 12 months | |
| Secondary | Change in Total Choroidal Neovascular Membrane (CNV) Size by Fluorescein Angiography From Baseline to Month 12 | 12 months | |
| Secondary | Foveal Thickness Measured Using Optical Coherence Tomography (OCT) From Baseline to Month 12 | 12 months |
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 | Mean Change in Early Treatment for Diabetic Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) From Baseline to Month 12 | 12 months | ETDRS Letters | MEAN | |
| PRIMARY | Mean Number of Re-treatment Injections of Lucentis® Per Patient, Per Year. | 12 months | injections per patient per year | MEAN | |
| SECONDARY | Percentage of Subjects Losing < 15 ETDRS Letters | 12 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Percentage of Subjects Gaining ≥ 0 ETDRS Letters | 12 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Percentage of Subjects Gaining ≥ 15 ETDRS Letters | 12 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Change in Total Lesion Size by Fluorescein Angiography From Baseline to Month 12 | 12 months | mm2 | MEAN | |
| SECONDARY | Change in Total Choroidal Neovascular Membrane (CNV) Size by Fluorescein Angiography From Baseline to Month 12 | 12 months | mm2 | MEAN | |
| SECONDARY | Foveal Thickness Measured Using Optical Coherence Tomography (OCT) From Baseline to Month 12 | 12 months | μm | MEAN |
Source ClinicalTrials.gov
Results by group16
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 for Diabetic Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) From Baseline to Month 12 | Arm A: Epimacular Bracytherapy + Lucentis® | -4.8 | Standard Deviation 10.8 | ETDRS Letters | |
| Mean Change in Early Treatment for Diabetic Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) From Baseline to Month 12 | Arm B: Lucentis® Only | -0.9 | Standard Deviation 9.7 | ETDRS Letters | |
| Mean Number of Re-treatment Injections of Lucentis® Per Patient, Per Year. | Arm A: Epimacular Bracytherapy + Lucentis® | 4.8 | Standard Deviation 3.2 | injections per patient per year | |
| Mean Number of Re-treatment Injections of Lucentis® Per Patient, Per Year. | Arm B: Lucentis® Only | 4.1 | Standard Deviation 2.4 | injections per patient per year | |
| Percentage of Subjects Losing < 15 ETDRS Letters | Arm A: Epimacular Bracytherapy + Lucentis® | 204 | Participants | ||
| Percentage of Subjects Losing < 15 ETDRS Letters | Arm B: Lucentis® Only | 110 | Participants | ||
| Percentage of Subjects Gaining ≥ 0 ETDRS Letters | Arm A: Epimacular Bracytherapy + Lucentis® | 91 | Participants | ||
| Percentage of Subjects Gaining ≥ 0 ETDRS Letters | Arm B: Lucentis® Only | 55 | Participants | ||
| Percentage of Subjects Gaining ≥ 15 ETDRS Letters | Arm A: Epimacular Bracytherapy + Lucentis® | 3 | Participants | ||
| Percentage of Subjects Gaining ≥ 15 ETDRS Letters | Arm B: Lucentis® Only | 6 | Participants |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm A: Epimacular Bracytherapy + Lucentis® | 244 | |
| Overall Study | STARTED | Arm B: Lucentis® Only | 119 | |
| Overall Study | COMPLETED | Arm A: Epimacular Bracytherapy + Lucentis® | 233 | |
| Overall Study | COMPLETED | Arm B: Lucentis® Only | 115 | |
| Overall Study | NOT COMPLETED | Arm A: Epimacular Bracytherapy + Lucentis® | 11 | |
| Overall Study | NOT COMPLETED | Arm B: Lucentis® Only | 4 |
Source ClinicalTrials.gov
Adverse events14
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 | Cataract | Eye disorders | Arm A: Epimacular Brachytherapy + Lucentis® | 82 | 244 | 82 |
| other | Cataract | Eye disorders | Arm B (Control): Lucentis ® Only | 11 | 119 | 11 |
| other | Visual acuity reduced | Eye disorders | Arm A: Epimacular Brachytherapy + Lucentis® | 39 | 244 | 39 |
| other | Visual acuity reduced | Eye disorders | Arm B (Control): Lucentis ® Only | 8 | 119 | 8 |
| other | Ocular Adverse Events in Study Eye | Eye disorders | Arm A: Epimacular Brachytherapy + Lucentis® | 127 | 244 | 127 |
| other | Ocular Adverse Events in Study Eye | Eye disorders | Arm B (Control): Lucentis ® Only | 31 | 119 | 31 |
| serious | Endophthalmitis | Eye disorders | Arm A: Epimacular Brachytherapy + Lucentis® | 1 | 244 | 1 |
| serious | Endophthalmitis | Eye disorders | Arm B (Control): Lucentis ® Only | 0 | 119 | |
| serious | Postoperative uveitis | Eye disorders | Arm A: Epimacular Brachytherapy + Lucentis® | 2 | 244 | 2 |
| serious | Postoperative uveitis | Eye disorders | Arm B (Control): Lucentis ® Only | 0 | 119 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm A: Epimacular Brachytherapy + Lucentis® | 3 | 244 |
| Total, all-cause mortality | Arm B (Control): Lucentis ® Only | 5 | 119 |
| Total, other adverse events | Arm A: Epimacular Brachytherapy + Lucentis® | 244 | 244 |
| Total, other adverse events | Arm B (Control): Lucentis ® Only | 50 | 119 |
| Total, serious adverse events | Arm A: Epimacular Brachytherapy + Lucentis® | 7 | 244 |
| Total, serious adverse events | Arm B (Control): Lucentis ® Only | 0 | 119 |
Source ClinicalTrials.gov
Papers4
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 comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Arm A: Epimacular Bracytherapy + Lucentis® vs Arm B: Lucentis® Only: Percentage of Subjects Gaining ≥ 15 ETDRS Letters | Trial comparisons |
| Arm A: Epimacular Bracytherapy + Lucentis® vs Arm B: Lucentis® Only: Percentage of Subjects Gaining ≥ 0 ETDRS Letters | Trial comparisons |
| Arm A: Epimacular Bracytherapy + Lucentis® vs Arm B: Lucentis® Only: Percentage of Subjects Losing < 15 ETDRS Letters | Trial comparisons |
| Arm A: Epimacular Brachytherapy + Lucentis® vs Arm B (Control): Lucentis ® Only: deaths from any cause | Trial comparisons |
| Arm A: Epimacular Brachytherapy + Lucentis® vs Arm B (Control): Lucentis ® Only: 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/NCT01006538
GET https://conductscience.org/api/trials/v1/NCT01006538/registered