Symptomatic Focal Vitreomacular Adhesion
Conditions
Brief summary
Evaluate the safety and efficacy of ophthalmic intravitreal injection of ALG-1001 in human subjects with symptomatic focal vitreomacular adhesion
Interventions
DRUG2.0mg of ALG-1001
Sponsors
Allegro Ophthalmics, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Symptomatic focal vitreomacular adhesion 2. Vitreomacular traction syndrome 3. Stage 1 and 2 macular holes, ≤ 350 µm 4. BCVA of 20/25 Early Treatment Diabetic Retinopathy Study (ETDRS) or worse in the study eye 5. BCVA of 20/800 ETDRS or better in the fellow eye 6. Male or female subjects, 18 years of age or older 7. Signed Informed Consent
Exclusion criteria
1. High myopes \> -8.0 D spherical equivalent 2. History of prior vitrectomy in the study eye 3. History of photocoagulation to the retina in the study eye 4. Macular hole in the study eye \> 350 µm 5. Subjects with epiretinal membranes in the study eye 6. Subjects with broad VMA, defined as VMA of \>1500 µm 7. Subjects with proliferative Diabetic Retinopathy (DR), neovascular Age-related Macular Degeneration (AMD), or retinal vascular occlusion in the study eye 8. Subjects with aphakia in the study eye 9. Subjects with uncontrolled glaucoma 10. Subjects with lenticular or zonular instability 11. Subjects with prior ocular surgery or intravitreal injection in the study eye within 90 days of study enrollment 12. Pregnant or nursing women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Release of Vitreo Macular Adhesion (VMA) by Optical Coherence Tomography (OCT) | 90 Days | The primary endpoint of this study is observation of pharmacologic resolution of VMA, with VMA defined as vitreous adhesion to the macula within a 6mm central retinal field surrounded by elevation of the posterior vitreous cortex as seen on OCT. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 2.0mg of ALG-1001 2.0mg of ALG-1001
2.0mg of ALG-1001 | 23 |
| Intravitreal Injection in 0.05cc BSS Balanced Salt Solution
Balanced Salt Solution | 22 |
| Total | 45 |
Baseline characteristics
| Characteristic | Intravitreal Injection in 0.05cc BSS | 2.0mg of ALG-1001 | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 4 Participants | 2 Participants | 6 Participants |
| Age, Categorical Between 18 and 65 years | 18 Participants | 21 Participants | 39 Participants |
| Age, Continuous | 49 years | 49 years | 49 years |
| Region of Enrollment United States | 22 Participants | 23 Participants | 45 Participants |
| Sex: Female, Male Female | 10 Participants | 11 Participants | 21 Participants |
| Sex: Female, Male Male | 12 Participants | 12 Participants | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 23 | 0 / 22 |
| other Total, other adverse events | 0 / 23 | 0 / 22 |
| serious Total, serious adverse events | 0 / 23 | 0 / 22 |
Outcome results
Primary
Release of Vitreo Macular Adhesion (VMA) by Optical Coherence Tomography (OCT)
The primary endpoint of this study is observation of pharmacologic resolution of VMA, with VMA defined as vitreous adhesion to the macula within a 6mm central retinal field surrounded by elevation of the posterior vitreous cortex as seen on OCT.
Time frame: 90 Days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 2.0mg of ALG-1001 | Release of Vitreo Macular Adhesion (VMA) by Optical Coherence Tomography (OCT) | 4 Participants |
| Intravitreal Injection in 0.05cc BSS | Release of Vitreo Macular Adhesion (VMA) by Optical Coherence Tomography (OCT) | 0 Participants |