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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON24763

Enrollment

Registered

2006-06-15

Start date

2006-07-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Central Retinal Vein Occlusion (CRVO)

Interventions

Injection of rt-PA (0.2 mg/ml, 4 ml) in retinal branch vein.

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
BCVA on ETDRS chart.	—

Secondary

Measure	Time frame
Reduction in: 1. Neovascular changes; 2. Neovascular glaucoma; 3. Rates of development of macular oedema.	—

Contacts

Public ContactK.A. Overdam, van

Oogziekenhuis Rotterdam, Schiedamsevest 180

kvoverdam@oogziekenhuis.nl+31 (0)10 4017777

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)