Intravitreal Triamcinolone with Transpupillary Thermal Therapy (TTT) for Subfoveal Choroidal Neovascularization in Age Related Macular Degeneration

ISRCTN	ISRCTN74123635
DOI	https://doi.org/10.1186/ISRCTN74123635
Protocol serial number	N/A
Sponsor	Association to Avoid Blindness (Asociación Para Evitar La Ceguera) (APEC) (Mexico)
Funder	Association to Avoid Blindness (Asociación Para Evitar La Ceguera) (APEC) (Mexico)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Ricardo Agurto-Rivera
Scientific

Exequiel Fernández nº 920
Casa F
Ñuñoa
Santiago
Chile

Phone	+56 8 5021968
Email	ricardo_agurto@yahoo.com

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	TTT plus intravitreous triamcinolone are effective treatment for choroidal neovascularization and are better than TTT alone.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Age-Related Macular Degeneration (ARMD) not available for current therapies
Intervention	Complete ophthalmologic examination, treatment with TTT alone compared with treatment with TTT plus intravitreous Triamcinolone. Ophthalmologic control to verify closure of CNV or re-treatment.
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Triamcinolone
Primary outcome measure(s)	Preservation of visual acuity
Key secondary outcome measure(s)	Closure of CNV, OCT characteristics
Completion date	28/02/2006

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	200
Key inclusion criteria	Patients with severe ARMD (choroidal neovascularization [CNV]) that could not be treated with photodynamic therapy (PDT) because of bad prognosis or economical reasons.
Key exclusion criteria	1. Any patient that has indication for PDT and has the economical means to get this therapy 2. Media opacity 3. Previous treatment for CNV
Date of first enrolment	01/02/2004
Date of final enrolment	28/02/2006

Exequiel Fernández nº 920

Santiago
Chile

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	25/11/2005		Yes	No