Rhegmatogenous Macula-off Retinal Detachment MedDRA version: 12.1 Level: LLT Classification code 10065569 Term: Rhegmatogenous retinal detachment
Conditions
Sponsors
Allergan Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female age = 18 years 2. The macula-off retinal detachment (including fovea) must have been rhegmatogenous in etiology; no suspected combined mechanism is permitted in the study eye 3. The repair of the macula-off retinal detachment must have occurred at least 6 months before the Day 1 visit in the study eye 4. No evidence of macular detachment or macular edema on screening optical coherence tomography (OCT) in the study eye 5. The best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity score must be = 24 letters (ie, approximately 20/320 or better) and = 65 letters (ie, approximately 20/50 or worse) in the study eye at screening and Day 1 and, in the opinion of the investigator, the decreased visual acuity is due to rhegmatogenous macula-off (including fovea) retinal detachment 6. The best-corrected ETDRS visual acuity in the non-study eye at screening is = 24 letters (approximately 20/320 or better) 7. The repair of the detachment must have been deemed an anatomic success, and must have required no more than one macular re-attachment procedure (at least 6 months before the Day 1 visit) in the study eye 8. Media clarity, pupillary dilation, and patient cooperation sufficient for adequate clinical evaluation of posterior pole and for adequate visualization of DDS® in the study eye 9. Women of childbearing potential must have a negative urine pregnancy test at the screening visit and prior to treatment on Day 1. A woman is considered of childbearing potential unless she is postmenopausal and without menses for 12 months or is surgically sterilized 10. Written informed consent has been obtained 11. Written Authorization for Use and Release of Health and Research Study Information (US sites only) has been obtained 12. Written Data Protection Consent (European sites only) has been obtained 13. Written documentation has been obtained in accordance with state and country privacy requirements, where applicable 14. Ability to understand the informed consent and willingness to follow study instructions and likely to complete all required visits and procedures Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Any sight-threatening ocular condition in the study eye other than RRD such as age-related macular degeneration, proliferative vitreo-retinopathy, moderate to severe diabetic retinopathy, epiretinal membrane or glaucoma requiring treatment that can interfere with the diagnosis or the assessment of disease progression or in the opinion of the investigator would prevent a 15-letter improvement in visual acuity 2. Silicone oil in the vitreous cavity of the study eye 3. Residual subretinal fluid in the macula or macular edema in the study eye by OCT or clinical exam 4. Cataract in the study eye defined as likely to: a. require cataract surgery during the study or b. contribute to worsening BCVA during the study or c. prevent a 3-line improvement 5. Aphakia or presence of anterior chamber intraocular lens in the study eye 6. Anticipated need for ocular surgery in the study eye during the 12-month study period 7. Any injectable, periocular, or intravitreal corticosteroid treatment to the study eye within 6 months prior to screening (eg, triamcinolone acetonide) or any injectable, periocular, or intravitreal anti-VEGF treatment to the study eye within 3 months prior to screening (eg, Avastin or Lucentis) 8. Any infectious condition in the study eye 9. Use of brimonidine, apraclonidine, or any other topical alpha-2 agonist in the study eye within 2 weeks prior to the screening visit or anticipated use during the study 10. Use of systemic alpha-2 antagonists (eg, phentolamine, phenoxybenzamine, yohimbine, idazoxan) or systemic alpha-2 agonists (eg, clonidine) within 2 weeks prior to the screening visit or anticipated use during the study 11. Sight-threatening disease in the non study eye 12. Known allergy to brimonidine tartrate or any component of the delivery vehicle or diagnostic agents used during the study (eg, dilation drops). 13. Contraindication to pupil dilation in either eye 14. Uncontrolled systemic disease 15. Female patients who are pregnant, nursing, or planning a pregnancy, or who are of childbearing potential and not using a reliable means of contraception 16. Any condition or reason (including inability to read ETDRS chart or language barrier) that precludes the patient’s ability to comply with study requirements including completion of the study 17. Current enrollment in an investigational drug or device study or participation in such a study within 30 days prior to the screening visit 18. Patient has a condition or is in a situation that in the investigator's opinion may put the patient at significant risk, may confound the study results, or may interfere significantly with the patient's participation in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of the Brimo PS DDS® Applicator System (200 µg and 400 µg brimonidine tartrate) on visual function in patients with previous rhegmatogenous macula-off retinal detachment To evaluate the safety of the Brimo PS DDS® Applicator System (200 µg and 400 µg brimonidine tartrate) in patients with previous rhegmatogenous macula-off retinal detachment ;Secondary Objective: N/A;Primary end point(s): Efficacy measures: Primary efficacy measure: BCVA (Early Treatment Diabetic Retinopathy Study [ETDRS] method) Other efficacy measures: reading speed (selected sites), Humphrey visual field (selected sites), microperimetry (selected sites), and sweep visual evoked potential (VEP) (optional at selected sites) Other prognostic measures: Stratus optical coherence tomography (OCT), Fourier Domain OCT (selected sites) Health outcome measures: vision-related quality of life (patient-reported outcomes) using the National Eye Institute 25-Item Visual Functioning Questionnaire (NEI-VFQ-25) Safety measures: Adverse events, BCVA by ETDRS, reading speed (selected sites), biomicroscopy, intraocular pressure (IOP), indirect ophthalmoscopy, vital signs (blood pressure, pulse, respiration), DDS® residual assessment | — |
Countries
United Kingdom
Outcome results
None listed