Comparison of Therapeutic Effects Between Intravitreal Injection of Bevacizumab With Intravitreal Injection of Bevacizumab and Targeted Laser Photocoagulation of Non Perfused Areas of Retina in Patients With Acute Retinal Vein Occlusion (bevacizumab)
Patients with new onset retinal vein occlusion in less than 3 month whom has visual acuity less than 20/40 and central macular thickness more than 250micrometer and non perfused areas of retina more than 10 DD are included in over study and devided into 2 groups randomizely, Group A under gone 3 intravitreal injection of bevacizumab monthly and examine monthly for Visual acuity and central macular thickness, if in month four or more the CMT is more than 250 micrometer and the visual acuity is less than 8/10 the injection is repeated and follow up in this manner is continued until 9 months.
Group B is as the same of group A but patients in this group undergone laser photocoagulation of retinal non perfused areas based on FAG wide field imaging .
After 9 month follow up the outcomes such as Vusal acuity, Central macular thickness, intraocular pressure, neovascular formation are compared,
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Fase 2
- Fase 3
Kontakter og lokationer
Studiesteder
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Tehran, Iran, Islamisk Republik
- Rekruttering
- Ophthalmic Research Center
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Kontakt:
- alireaza ramezani, MD
- Telefonnummer: 009822591616
- E-mail: labbafi@hotmail.com
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Center-involved macular edema secondary to RVO on clinical exam
- Symptoms less than 3 months
- BCVA= 20/40 or worse
- Mean center point thickness >250 μm
- Media clarity, pupillary dilation, and subject cooperation sufficient for adequate fundus photographs
One eye per participant is enrolled in the trial
Exclusion Criteria:
- Macular edema due to a cause other than CRVO
- An ocular condition such that visual acuity would not improve from resolution of the edema (eg, foveal atrophy)
- Substantial cataract estimated to have reduced visual acuity by >3 lines
- Prior treatment with intravitreal or peribulbar steroid injection
- History of macular photocoagulation or PRP
- Prior pars plana vitrectomy
- Hx of Intraocular surgery (including cataract extraction)
- uveitis, NVG, exudative AMD, diabetic retinopathy, any malignancy, optic neuropathy, amblyopia
- vitreomacular traction or epiretinal membrane *uncontrolled glaucoma ( > 30mmHg with anti-glaucoma medications)
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Aktiv komparator: intravitreal injection of bevacizumab
|
under gone 3 intravitreal injection of bevacizumab monthly and examine monthly for Visual acuity and central macular thickness, if in month four or more the CMT is more than 250 micrometer and the visual acuity is less than 8/10 the injection is repeatet and follow up in this manner is continued until 9 months.
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Aktiv komparator: intravitreal injection of bevacizumab+ targeted laser
Intervention intravitreal bevacizumab injection + targeted laser photocoagulation of retinal non perfused areas
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patients in this group undergone laser photocoagulation of retinal non perfused areas based on FAG wide field imaging . After 9 month follow up the outcomes such as Vusal acuity, Central macular thickness, intraocular pressure, neovascular formation are compared |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Visual acuity
Tidsramme: Every month
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Snellen chart
|
Every month
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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macular thickness
Tidsramme: every month
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OCT
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every month
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Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Hjerte-kar-sygdomme
- Karsygdomme
- Øjensygdomme
- Nethindedegeneration
- Nethindesygdomme
- Embolisme og trombose
- Venøs trombose
- Trombose
- Makuladegeneration
- Makulaødem
- Retinal veneokklusion
- Lægemidlers fysiologiske virkninger
- Antineoplastiske midler
- Antineoplastiske midler, immunologiske
- Angiogenese-hæmmere
- Angiogenesemodulerende midler
- Vækststoffer
- Væksthæmmere
- Bevacizumab
Andre undersøgelses-id-numre
- 9696
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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