Trial · NCT04292912
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GSK2798745 in Participants With Diabetic Macular Edema
NCT04292912, Phase 1, Terminated, GlaxoSmithKline; results first posted 2024-11-08
3 sourcestrials-2026-11-12-0.4.0
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ConductScience Library. A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GSK2798745 in Participants With Diabetic Macular Edema. Trials, record NCT04292912. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04292912
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GSK2798745 in Participants With Diabetic Macular Edema
- NCT number
- NCT04292912
- Status
- Terminated
- Phases
- Phase 1
- Enrollment
- 16 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Macular Edema
- Interventions
- GSK2798745
- First posted
- 2020-03-03
- Last updated
- 2024-11-08
- Results first posted
- 2024-11-08
- Limitations and caveats
- The study was early terminated as the study met the prespecified threshold for futility for both SD-OCT and BCVA endpoints of the study based on IA.
Source ClinicalTrials.gov
Registered outcomes27
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Abnormal Ophthalmic Examination Findings | Up to Day 28 | Ophthalmic examinations for Pupil motility and confrontation visual field examination, slit lamp evaluation of anterior ocular structures, intraocular pressure measurement and optical coherence tomography (OCT) was performed on left and right eye. Participants with data including abnormalities of potential clinical importance is listed here. |
| Primary | Mean Change From Baseline to Day 28 in Visual Acuity | Baseline and Day 28 | Best-correct visual acuity (BCVA) was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. The visual function of the study eye was assessed using the ETDRS protocol. ETDRS letters score can be calculated when 20 or more letters are read correctly at 4.0 meters (m); the visual acuity letter score is equal to the total number of letters read correctly at 4.0 m plus 30. If less than 20 letters are read correctly at 4.0 m, the visual acuity letter score is equal to the total number of letters read correctly at 4.0 m (number of letters recorded on line 1.0), plus the total number of letters read correctly at 1.0 m in the first six lines. The score ranges from 0-100 where a higher score represents better visual functioning. The change from baseline was calculated by subtracting baseline value from post-baseline value. |
| Primary | Mean Change From Baseline to Day 28 in Body Weight | Baseline and Day 28 | Physical examination included the measuring of body weight and evaluated at indicated time points. The change from baseline was calculated by subtracting baseline value from post-baseline value. |
| Primary | Mean Change From Baseline to Day 28 in Body Temperature | Baseline and Day 28 | Physical examination included the measuring of body temperature and evaluated at indicated time points. The change from Baseline was calculated by subtracting Baseline value from post-Baseline value. |
| Primary | Mean Change From Baseline to Day 28 in Vital Signs for Systolic Blood Pressure and Diastolic Blood Pressure | Baseline and Day 28 | The change from baseline for Systolic Blood Pressure (SBP) and Diastolic blood Pressure (DBP) was calculated by subtracting baseline value from post-baseline value. |
| Primary | Mean Change From Baseline to Day 28 in Pulse Rate | Baseline and Day 28 | Pulse rate was measured at indicated time points. The change from baseline was calculated by subtracting baseline value from post-baseline value. |
| Primary | Mean Change From Baseline to Day 28 in 12-lead Electrocardiogram (ECG) Findings | Baseline and Day 28 | The 12-lead ECGs was obtained at indicated timepoints during the study. The standard ECG criteria of potential clinical importance were 1) absolute QTc Interval, \> 450 milliseconds (msec), 2) absolute PR Interval, \<110 msec, 3) absolute QRS Interval, \< 75 msec and 4) increase from baseline in QTc \> 60 msec. The change from baseline was calculated by subtracting baseline value from post-baseline value. |
| Primary | Mean Change From Baseline to Day 28 in Alanine Amino Transferase (ALT), Alkaline Phosphatase (AP), Aspartate Amino Transferase (AST), and Creatine Kinase | Baseline and Day 28 | Summary of changes from baseline in laboratory parameters were assessed. The analysis included liver function tests for ALT, AP, AST, Creatine kinase and evaluated at indicated time points. The change from baseline was calculated by subtracting baseline value from post-baseline value. |
| Primary | Mean Change From Baseline to Day 28 in Calcium, Glucose, Potassium, Sodium, and Urea Nitrogen | Baseline and Day 28 | Summary of changes from baseline in clinical chemistry parameters. The parameters included were calcium, glucose, potassium, sodium and urea nitrogen and evaluated at indicated time points. The change from baseline was calculated by subtracting baseline value from post-baseline value. |
| Primary | Mean Change From Baseline to Day 28 in Creatinine, Total Bilirubin, and Direct Bilirubin | Baseline and Day 28 | Summary of changes from baseline in clinical chemistry parameters. The parameters analyzed were creatinine, total bilirubin and direct bilirubin and evaluated at indicated timepoints. The change from baseline was calculated by subtracting baseline value from post-baseline value. |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 registered outcomesOutcomes27
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 Abnormal Ophthalmic Examination Findings | Up to Day 28 | Modified safety population comprised of all participants who received at least one dose of study treatment. Only those participants available at the time of assessment were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Mean Change From Baseline to Day 28 in Visual Acuity | Baseline and Day 28 | Pharmacodynamics (PD) analysis set included all participants from the modified Safety population who had at least 1 post-baseline non-missing PD assessment. | Letters | MEAN |
| PRIMARY | Mean Change From Baseline to Day 28 in Body Weight | Baseline and Day 28 | Modified safety population comprised of all participants who received at least one dose of study treatment. Only those participants available at the time of assessment were analyzed. | kilogram (kg) | MEAN |
| PRIMARY | Mean Change From Baseline to Day 28 in Body Temperature | Baseline and Day 28 | Modified safety population comprised of all participants who received at least one dose of study treatment. Only those participants available at the time of assessment were analyzed. | Degree Celsius (°C) | MEAN |
| PRIMARY | Mean Change From Baseline to Day 28 in Vital Signs for Systolic Blood Pressure and Diastolic Blood Pressure | Baseline and Day 28 | Modified safety population comprised of all participants who received at least one dose of study treatment. Only those participants available at the time of assessment were analyzed. | mmHg | MEAN |
| PRIMARY | Mean Change From Baseline to Day 28 in Pulse Rate | Baseline and Day 28 | Modified safety population comprised of all participants who received at least one dose of study treatment. Only those participants available at the time of assessment were analyzed. | Beats per Minute (beats/min) | MEAN |
| PRIMARY | Mean Change From Baseline to Day 28 in 12-lead Electrocardiogram (ECG) Findings | Baseline and Day 28 | The intensive pharmacokinetics (PK) analysis population included all participants from the modified Safety population who had intensive PK sampling on Day 7 and Day 28. However, since only one participant consented to intensive PK and this participant withdrew early, before Day 28, data for this endpoint were not collected. | ||
| PRIMARY | Mean Change From Baseline to Day 28 in Alanine Amino Transferase (ALT), Alkaline Phosphatase (AP), Aspartate Amino Transferase (AST), and Creatine Kinase | Baseline and Day 28 | Modified safety population comprised of all participants who received at least one dose of study treatment. Only those participants available at the time of assessment were analyzed. | Microkatal per Litre (ukat/L) | MEAN |
| PRIMARY | Mean Change From Baseline to Day 28 in Calcium, Glucose, Potassium, Sodium, and Urea Nitrogen | Baseline and Day 28 | Modified safety population comprised of all participants who received at least one dose of study treatment. Only those participants available at the time of assessment were analyzed. | Millimoles per Liter (mmol/L) | MEAN |
| PRIMARY | Mean Change From Baseline to Day 28 in Creatinine, Total Bilirubin, and Direct Bilirubin | Baseline and Day 28 | Modified safety population comprised of all participants who received at least one dose of study treatment. Only those participants available at the time of assessment were analyzed. | Micromoles per Liter (umol/L) | MEAN |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 outcomesResults by group52
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 Abnormal Ophthalmic Examination Findings | GSK2798745 | Eyelids and Lashes | 0 | Participants | |
| Number of Participants With Abnormal Ophthalmic Examination Findings | GSK2798745 | Pupil motility | 0 | Participants | |
| Number of Participants With Abnormal Ophthalmic Examination Findings | GSK2798745 | Confrontation visual field examination | 0 | Participants | |
| Number of Participants With Abnormal Ophthalmic Examination Findings | GSK2798745 | Slit lamp evaluation of anterior ocular structures | 0 | Participants | |
| Number of Participants With Abnormal Ophthalmic Examination Findings | GSK2798745 | Intraocular pressure measurement, Left eye | 1 | Participants | |
| Number of Participants With Abnormal Ophthalmic Examination Findings | GSK2798745 | Intraocular pressure measurement, Right eye | 1 | Participants | |
| Number of Participants With Abnormal Ophthalmic Examination Findings | GSK2798745 | OCT center subfield, Left eye | 0 | Participants | |
| Number of Participants With Abnormal Ophthalmic Examination Findings | GSK2798745 | OCT center subfield, Right eye | 1 | Participants | |
| Mean Change From Baseline to Day 28 in Visual Acuity | GSK2798745 | 1.6 | Standard Deviation 4.67 | Letters | |
| Mean Change From Baseline to Day 28 in Body Weight | GSK2798745 | -0.34 | Standard Deviation 1.157 | kilogram (kg) |
1 to 10 of 52Source ClinicalTrials.gov
See all 52 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | GSK2798745 | 16 | |
| Overall Study | COMPLETED | GSK2798745 | 9 | |
| Overall Study | NOT COMPLETED | GSK2798745 | 7 |
Source ClinicalTrials.gov
Adverse events6
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 | Diabetic retinal oedema | Eye disorders | GSK2798745 | 1 | 16 | 1 |
| other | Diarrhoea | Gastrointestinal disorders | GSK2798745 | 1 | 16 | 1 |
| other | Feeling abnormal | General disorders | GSK2798745 | 1 | 16 | 1 |
| other | Vision blurred | Eye disorders | GSK2798745 | 1 | 16 | 1 |
| other | Diabetes mellitus | Metabolism and nutrition disorders | GSK2798745 | 1 | 16 | 1 |
| other | Vitreous floaters | Eye disorders | GSK2798745 | 1 | 16 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | GSK2798745 | 0 | 16 |
| Total, other adverse events | GSK2798745 | 4 | 16 |
| Total, serious adverse events | GSK2798745 | 0 | 16 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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/NCT04292912
GET https://conductscience.org/api/trials/v1/NCT04292912/registered?page=2