A Phase 2 interventional study of IVT aflibercept and Sham SC in Diabetic Macular Edema, sponsored by Clearside Biomedical, Inc.. Completed at 29 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-05-13.
Sponsored by Clearside Biomedical, Inc. · Phase 2, Interventional, and Treatment
The purpose of this trial is to evaluate the safety and efficacy of suprachoroidal CLS-TA used with intravitreal aflibercept in subjects with DME.
This is a Phase 2, multicenter, randomized, double-masked, controlled, parallel-group study of 6 months duration in treatment-naïve subjects with DME. This study is projected to enroll approximately 60 subjects, randomly assigned 1:1 to one of two treatment groups.
The study design includes up to 8 clinic visits over approximately 24 weeks. Subjects will attend visits for Screening (Visit 1, Days -30 to 0); Randomization and Baseline (Visit 2, Day 0 before dosing); Dosing and Evaluation (Visit 2 after dosing to Visit 5, Day 0 through Week 12); As-needed (PRN) Dosing and Follow up (Visit 6 through Visit 7, Week 16 through Week 20), and End of Study (Visit 8, Week 24).
8,290 studies on the registry are indexed under Diabetes Mellitus; 1,077 are open to participants now.
This study's enrollment of 71 is below the median of 80 across 6,023 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Clearside Biomedical, Inc. is the lead sponsor of 14 studies on the registry; none are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 7 (88%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Treatment will consist of IVT injection of Aflibercept followed by an SC injection of CLS-TA
Drug: IVT aflibercept · Drug: SC CLS-TA
Treatment will consist of IVT aflibercept injection followed by a sham SC procedure
Drug: IVT aflibercept · Drug: Sham SC
IVT aflibercept \[2 mg/0.05 mL\]
Also known as: Eylea
sham SC
Also known as: suprachoroidal sham
CLS-TA \[4 mg/100 μL\] SC injection
Also known as: Triamcinolone Acetonide
Mean Change From Baseline in Best Corrected Visual Acuity Letter Score
Best corrected visual acuity (BCVA) refers to the measurement of the best possible vision that can be achieved following refraction or correction. BCVA was assessed following the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol and was measured in the number of letters read correctly on an ETDRS eye chart. An increase from the pre-treatment state in BCVA of 15 letters or more represents a clinically meaningful improvement.
Time frame: Baseline, 6 months
Mean Change From Baseline in Central Subfield Thickness
Central subfield thickness (CST) is a diagnostic measurement used in identifying the presence of edema in the circular area 1 mm in diameter centered around the fovea. CST was measured using spectral domain optical coherence tomography (SD-OCT). A masked reading center graded the SD-OCT digital images. A negative change from baseline value represents a reduction in macular edema.
Time frame: Baseline, 6 months
| Milestone | Active | Control |
|---|---|---|
| Started | 36 | 35 |
| Completed | 30 | 33 |
| Not completed | 6 | 2 |
| Withdrew: Adverse event | 3 | 0 |
| Withdrew: Lost to follow-up | 0 | 1 |
| Withdrew: Withdrawal by subject | 3 | 1 |
Best corrected visual acuity (BCVA) refers to the measurement of the best possible vision that can be achieved following refraction or correction. BCVA was assessed following the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol and was measured in the number of letters read correctly on an ETDRS eye chart. An increase from the pre-treatment state in BCVA of 15 letters or more represents a clinically meaningful improvement.
| letters | Active | Control |
|---|---|---|
| Mean Change From Baseline in Best Corrected Visual Acuity Letter Score | 11.4 ± 1.63 | 13.8 ± 1.59 |
Central subfield thickness (CST) is a diagnostic measurement used in identifying the presence of edema in the circular area 1 mm in diameter centered around the fovea. CST was measured using spectral domain optical coherence tomography (SD-OCT). A masked reading center graded the SD-OCT digital images. A negative change from baseline value represents a reduction in macular edema.
| microns | Active | Control |
|---|---|---|
| Mean Change From Baseline in Central Subfield Thickness | -212.1 ± 13.83 | -178.6 ± 13.61 |
Collected over Adverse events were collected over 24 weeks of follow-up.. Non-serious events are listed at a 3% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Active | 2/36 (5.6%) | 6/36 (16.7%) | 10/36 (27.8%) |
| Control | 0/35 (0%) | 4/35 (11.4%) | 11/35 (31.4%) |
| Event | Active | Control |
|---|---|---|
| PneumoniaInfections and infestations | 2/36 | 0/35 |
| Acute left ventricular failureCardiac disorders | 0/36 | 1/35 |
| Acute myocardial infarctionCardiac disorders | 0/36 | 1/35 |
| OsteomyelitisInfections and infestations | 0/36 | 1/35 |
| Diabetic neuropathic ulcerSkin and subcutaneous tissue disorders | 0/36 | 1/35 |
| AnaemiaBlood and lymphatic system disorders | 1/36 | 0/35 |
| Cardiac arrestCardiac disorders | 1/36 | 0/35 |
| Hepatorenal syndromeHepatobiliary disorders | 1/36 | 0/35 |
| Pneumonia staphylococcalInfections and infestations | 1/36 | 0/35 |
| Femur fractureInjury, poisoning and procedural complications | 1/36 | 0/35 |
| Event | Active | Control |
|---|---|---|
| HypertensionVascular disorders | 3/36 | 4/35 |
| NasopharyngitisInfections and infestations | 0/36 | 3/35 |
| Intraocular pressure increasedEye disorders | 3/36 | 1/35 |
| Eye painEye disorders | 0/36 | 2/35 |
| Retinal exudatesEye disorders | 0/36 | 2/35 |
| AnxietyPsychiatric disorders | 2/36 | 0/35 |
| Conjunctival haemorrhageEye disorders | 2/36 | 1/35 |
The Safety population included all randomly assigned subjects who were administered at least 1 dose of the study drug.
| Age, Categorical(Participants) | Active | Control | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 25 | 23 | 48 |
| >=65 years | 11 | 12 | 23 |
| Age, Continuous(years) | Active | Control | Total |
|---|---|---|---|
| Mean | 59.8 ± 10.16 | 59.2 ± 12.89 | 59.5 ± 11.51 |
| Sex: Female, Male(Participants) | Active | Control | Total |
|---|---|---|---|
| Female | 10 | 11 | 21 |
| Male | 26 | 24 | 50 |
| Ethnicity (NIH/OMB)(Participants) | Active | Control | Total |
|---|---|---|---|
| Hispanic or Latino | 12 | 9 | 21 |
| Not Hispanic or Latino | 24 | 26 | 50 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Active | Control | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 1 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 3 | 2 | 5 |
| White | 31 | 32 | 63 |
| More than one race | 0 | 1 | 1 |
| Unknown or Not Reported | 1 | 0 | 1 |
| Region of Enrollment(participants) | Active | Control | Total |
|---|---|---|---|
| United States | 36 | 35 | 71 |
| Best corrected visual acuity(letters) | Active | Control | Total |
|---|---|---|---|
| Mean | 57.1 ± 13.00 | 58.1 ± 11.33 | 57.6 ± 12.13 |
PDFs hosted by the registry, ClinicalTrials.gov.
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This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Triamcinolone Acetonide
Clearside Biomedical, Inc.