rt-PA administration by retinal branch vein route for Central Retinal Vein Occlusion (CRVO). A Randomized - Conventional Therapy controlled – Trial.

Suspended

• Conditions: Central Retinal Vein Occlusion (CRVO)

• Registration Number: NL-OMON24763
• Lead Sponsor: Oogziekenhuis RotterdamSchiedamsevest 1803011 BH Rotterdam

Brief Summary

van Overdam KA, Missotten T, Spielberg LH. Updated cannulation technique for tissue plasminogen activator injection into peripapillary retinal vein for central retinal vein occlusion. Acta Ophthalmol. 2015; 93(8): 739-744.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Suspended
• Sex: Not specified
• Target Recruitment: 48

Inclusion Criteria

1. Informed consent;
2. >18 years of age;
3. Adequate birth control (if not post-menopausal or sterilised) during a 2 week pre- and 6 week post-op period if assigned to vitreoretinal surgery;
4. Subjective decrease in visual acuity starting within 4 weeks prior to study start, due to CRVO, clinically evident by fundoscopy;
5. Non-perfused or perfused CRVO with a visual acuity of less than 20/200.

Note : Pseudophakic patients are allowed to participate in this study.

Exclusion Criteria

1. Inability to visualize fundus due to corneal or important lenticular opacities;
2. Inability to obtain photographs of CRVO due to allergy to fluorescein or lack of veinous access;
3. As visual acuity prognosis is better and risk for neovascularisation is reduced in perfused CRVO, patients with a visual acuity > 20/200 will not be included;
4. Presence of iris neovascularisation (> grade 1) or anterior chamber angle (>grade 1) at the moment of presentation;
5. Other retinal or ophthalmic disorders that could influence the macular area;
6. Disorders that could be complicated by iris or retinal neovascularisation;
7. Disorders that could be complicated by any form of secondary glaucoma;
8. Prescription of acetazolamide or high dose systemic steroid (> 10 mg prednisone daily) or other anti-inflammatory medication (eg. MTX, Imuran, Endoxan, Humira, Kineret, Infliximab, Thalidomide) except NSAIDs;
9. Participation in another clinical ophthalmic trial;
10. Any surgery of the orbit, ocular adnexae or eye scheduled during the period the study (except for cataract surgery, developed after inclusion to a degree as outlined by the protocol);
11. Monophthalmia or other known ophthalmic disorder in the fellow eye that could be complicated by blindness;
12. Previous retinal surgery;
13. High myopia (-8 D spherical equivalent or more);
14. Macula affecting drugs.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
BCVA on ETDRS chart.

Secondary Outcome Measures

Name	Time	Method
Reduction in:<br>1. Neovascular changes; <br>2. Neovascular glaucoma; <br>3. Rates of development of macular oedema.