Intravitreal Bevacizumab associated with epiretinal brachitherapy as a treatment for Coroidal Neovascularization (CNV) secondary to exudative Age Related Macular Degeneration (AMD) - OFT-09-01

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-016926-15-IT

Enrollment

Registered

2010-03-23

Start date

2010-03-11

Completion date

Unknown

Last updated

2025-01-27

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

Conditions

exudative Age Related Macular Degeneration MedDRA version: 12.1 Level: LLT Classification code 10015902 Term: Exudative senile macular degeneration of retina

Interventions

Trade Name: AVASTIN Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Bevacizumab Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentratio

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients with CNV secondary to AMD, with an area ≤21.24 mm2 2. Patients must have completed 6 Bevacizumab intravitreal injections 3. Best corrected visual acuity within 69 and 24 ETDRS letters 4. subretinal haemorrhages smaller than 50% of the lesion area 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. Previous alternative treatment in the elected eye 2. Other ocular pathologies 3. Glaucomatous patients 4. CNV scarring bigger than 25% of the surface 5. Previous retina detachment 6. Haemovitreous 7. Previous vitrectomies

Design outcomes

Primary

Measure	Time frame
Main Objective: Evaluate the efficacy of associating intravitreal Bevacizumab with epiretinal brachitherapy in reducing the number of intravitreal injections necessary to control the neovascular coroidal growth, and consequently to stabilize or improve Visual Acuity;Secondary Objective: Evaluate number of ETDRS letters gained or lost Variations of the dimensions of the lesion OCT-measured foveal thickness Evaluation of adverse reactions;Primary end point(s): reduce the number of intravitreal injections necessary to control the neovascular coroidal growth,	—

Measure

Time frame

Main Objective: Evaluate the efficacy of associating intravitreal Bevacizumab with epiretinal brachitherapy in reducing the number of intravitreal injections necessary to control the neovascular coroidal growth, and consequently to stabilize or improve Visual Acuity;Secondary Objective: Evaluate number of ETDRS letters gained or lost Variations of the dimensions of the lesion OCT-measured foveal thickness Evaluation of adverse reactions;Primary end point(s): reduce the number of intravitreal injections necessary to control the neovascular coroidal growth,

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Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026