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A Depot Formulation of Sunitinib Malate (GB-102) Compared to Aflibercept in Subjects With Wet AMD
Phase 2 trial testing Drug: GB-102 in Neovascular Age-Related Macular Degeneration in 56 participants. Completed in 3 June 2021.
| Lead sponsor | Graybug Vision |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 56 |
| Start date | 26 September 2019 |
| Primary completion | 15 December 2020 |
| Estimated completion | 3 June 2021 |
| Sites | 33 locations across United States |
Graybug Vision — full company profile →
50 and older, any sex, with Neovascular Age-Related Macular Degeneration. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Kaplan-Meier estimate of the median time to first rescue treatment.
| Group | Value | 95% CI |
|---|---|---|
| GB-102 1 mg/1 mg | 5 | 3 – 8 |
| GB-102 2 mg/1 mg | 4 | 3 – 4 |
| Aflibercept 2 mg | NA | NA – NA |
Assessment of time to fulfillment of at least one rescue criterion starting at the Month 6 visit through to the Month 12 visit
| Group | Value | 95% CI |
|---|---|---|
| GB-102 1 mg/1 mg | 1.5 | 1 – 2 |
| GB-102 2 mg/1 mg | 2 | NA – NA |
| Aflibercept 2 mg | NA | 6 – NA |
Assessment of the number of monthly intervals that at least one rescue criterion is met
| Group | Value | 95% CI |
|---|---|---|
| GB-102 1 mg/1 mg | 5.1 | ± 3.38 |
| GB-102 2 mg/1 mg | 6.1 | ± 2.86 |
| Aflibercept 2 mg | 1.1 | ± 1.26 |
Assessment of the number of treatments, including both rescue and scheduled study treatments, that occurred during the study
| Group | Value | 95% CI |
|---|---|---|
| GB-102 1 mg/1 mg | 4 | 1 – 8 |
| GB-102 2 mg/1 mg | 4 | 1 – 7 |
| Aflibercept 2 mg | 6 | 3 – 7 |
BCVA = best corrected visual acuity; ETDRS = early treatment of diabetic retinopathy BCVA ETDRS range = 0 (worst) to 100 (best) Assessment of change in BCVA (ETDRS letter score) from baseline at all visits
| Group | Value | 95% CI |
|---|---|---|
| GB-102 1 mg/1 mg | -7.4 | ± 4.72 |
| GB-102 2 mg/1 mg | -5.1 | ± 4.37 |
| Dose | 1.8 | ± 0.97 |
BCVA = best corrected visual acuity; ETDRS = early treatment of diabetic retinopathy BCVA ETDRS range = 0 (worst) to 100 (best) Assessment of categorical change in BCVA (ETDRS letter score) from baseline at all visits
| Group | Value | 95% CI |
|---|---|---|
| GB-102 1 mg/1 mg | 7 | |
| GB-102 2 mg/1 mg | 4 | |
| Aflibercept 2 mg | 0 | |
| GB-102 1 mg/1 mg | 3 | |
| GB-102 2 mg/1 mg | 2 | |
| Aflibercept 2 mg | 2 | |
| GB-102 1 mg/1 mg | 1 | |
| GB-102 2 mg/1 mg | 1 | |
| Aflibercept 2 mg | 1 | |
| GB-102 1 mg/1 mg | 7 | |
| GB-102 2 mg/1 mg | 8 | |
| Aflibercept 2 mg | 5 |
Assessment of the frequency of subjects with BCVA worse than 20/200 (Snellen equivalent) at all visits A vision score of 20/20 is considered normal. A vision score of 20/200 is considered legally blind.
| Group | Value | 95% CI |
|---|---|---|
| GB-102 1 mg/1 mg | 3 | |
| GB-102 2 mg/1 mg | 1 | |
| Aflibercept 2 mg | 0 |
CST = central subfield thickness Assessment of change in CST (μm) measurement from baseline at all visits
| Group | Value | 95% CI |
|---|---|---|
| GB-102 1 mg/1 mg | 41.7 | ± 20.69 |
| GB-102 2 mg/1 mg | 27.2 | ± 11.07 |
| Aflibercept 2 mg | 7.8 | ± 15.46 |
Assessment of the frequency of subjects with absence of exudation (intra-/sub-retinal fluid/cystoid edema) at all visits
| Group | Value | 95% CI |
|---|---|---|
| GB-102 1 mg/1 mg | 2 | |
| GB-102 2 mg/1 mg | 3 | |
| Aflibercept 2 mg | 1 |
Time frame: Baseline to Month 18. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | GB-102 1 mg/1 mg | GB-102 2 mg/1 mg | Aflibercept 2 mg |
|---|---|---|---|---|
| Retinal detachment | Eye disorders | — | — | — |
| Pneumonia | Infections and infestations | — | — | — |
| Acute myeloid leukemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — | — |
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — | — |
| Atrial fibrillation | Cardiac disorders | — | — | — |
| Sepsis | Infections and infestations | — | — | — |
| Urosepsis | Infections and infestations | — | — | — |
| Metastatic gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — | — |
| Intraductal proliferative breast lesion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — | — |
| Reaction | System | GB-102 1 mg/1 mg | GB-102 2 mg/1 mg | Aflibercept 2 mg |
|---|---|---|---|---|
| Vitreous floaters | Eye disorders | — | — | — |
| Iritis | Eye disorders | — | — | — |
| Product residue present | Investigations | — | — | — |
| Eye pain | Eye disorders | — | — | — |
| Retinal haemorrhage | Eye disorders | — | — | — |
| Visual acuity reduced | Eye disorders | — | — | — |
| Cataract | Eye disorders | — | — | — |
| Episcleritis | Eye disorders | — | — | — |
| Nasopharyngitis | Infections and infestations | — | — | — |
| Sinusitis | Infections and infestations | — | — | — |
| Headache | Nervous system disorders | — | — | — |
| Subretinal fluid | Eye disorders | — | — | — |
| Visual impairment | Eye disorders | — | — | — |
| Vision blurred | Eye disorders | — | — | — |
| Dry eye | Eye disorders | — | — | — |
| Anterior chamber inflammation | Eye disorders | — | — | — |
| Cataract subcapsular | Eye disorders | — | — | — |
| Corneal oedema | Eye disorders | — | — | — |
| Keratic precipitates | Eye disorders | — | — | — |
| Photophobia | Eye disorders | — | — | — |
| Neovascular age-related macular degeneration | Eye disorders | — | — | — |
| Conjunctivitis | Infections and infestations | — | — | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Dementia | Nervous system disorders | — | — | — |
| Hypertension | Vascular disorders | — | — | — |
| Posterior capsule opacification | Eye disorders | — | — | — |
| Vitritis | Eye disorders | — | — | — |
| Subretinal fibrosis | Eye disorders | — | — | — |
| Conjunctival hyperaemia | Eye disorders | — | — | — |
| Retinal oedema | Eye disorders | — | — | — |
| Retinal thickening | Eye disorders | — | — | — |
| Uveitis | Eye disorders | — | — | — |
| Vitreous detachment | Eye disorders | — | — | — |
| Choroidal neovascularisation | Eye disorders | — | — | — |
| Dermatochalasis | Eye disorders | — | — | — |
| Eye allergy | Eye disorders | — | — | — |
| Iris adhesions | Eye disorders | — | — | — |
| Papilloedema | Eye disorders | — | — | — |
| Punctate keratitis | Eye disorders | — | — | — |
Most-reported serious reactions: Retinal detachment, Pneumonia, Acute myeloid leukemia, Bladder cancer, Atrial fibrillation, Sepsis, Urosepsis, Metastatic gastric cancer.
Data from ClinicalTrials.gov NCT03953079 adverse events section.
Phase 2b, multicenter, visual examiner-masked, randomized active-controlled, parallel-arm design study to evaluate the safety and duration of repeated IVT injections of 3 dose levels of GB-102 compared with aflibercept.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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