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
Secondary identifying numbers	N/A

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

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Triamcinolone
Primary outcome measure	Preservation of visual acuity
Secondary outcome measures	Closure of CNV, OCT characteristics
Overall study start date	01/02/2004
Completion date	28/02/2006

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	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

Association to Avoid Blindness (Asociación Para Evitar La Ceguera) (APEC) (Mexico)
Not defined

Vicente García Torres Nº 46
Barrio San Lucas
Del Coyoacán
Mexico City
04030
Mexico

Charity

Association to Avoid Blindness (Asociación Para Evitar La Ceguera) (APEC) (Mexico)

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	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