Last updated: April 13, 2021
Sponsor: University of Sydney
Overall Status: Active - Recruiting
Phase
N/A
Condition
Macular Edema
Treatment
N/AClinical Study ID
NCT04847869
NIRVO
Ages > 18 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Diagnosis macular edema secondary to branch or central vein occlusion (BRVO or CRVO)
- CMT of >300 µm and less than 550 µm;
- Best corrected visual acuity of 6/6 to 6/24 (letters 87 - 53);
- Intraocular pressure < 25 mmHg;
- Written informed consent has been obtained.
Exclusion
Exclusion Criteria:
- Loss of vision due to other causes (e.g. age-related macular degeneration, myopicmacular degeneration, DME);
- Known allergy to agents used in the study e.g. fluorescein;
- Women who are pregnant, nursing, or planning a pregnancy, or who are of childbearingpotential and not using reliable means of contraception;
- Only eye (vision in other eye <6/60);
- Study eye is an amblyopic eye;
- Macular oedema due to other causes;
- Significant diabetic retinopathy;
- An ocular condition that would prevent visual acuity improvement despite resolution ofoedema (such as foveal atrophy or substantial premacular fibrosis;
- Previous treatment with any anti-VEGF therapy or investigational drugs in the studyeye at any time prior to baseline.
- Previous use of intraocular or periocular steroids in study eye at any time prior tobaseline;
- Cataract surgery within the last 3 months;
- Retinal laser treatment within the last 6 months;
- Media opacity including cataract that already precludes adequate macular photographyor cataract that is likely to require surgery within 6 months;
- Intercurrent severe disease such as septicaemia, any condition which would affectfollow-up;
- History of chronic renal failure requiring dialysis or renal transplant;
- Blood pressure >180/120;
- Participant has a condition or is in a situation that in the investigator's opinionmay put the participant at significant risk, may confound the study results, or mayinterfere significantly with the participant's participation in the study
Study Design
Total Participants: 14
Study Start date:
January 01, 2021
Estimated Completion Date:
July 31, 2022
Study Description
Connect with a study center
Macular Research Group, Save Sight Institute, The University of Sydney
Sydney, New South Wales 2000
AustraliaActive - Recruiting
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