Clinical Studies at The Retina Clinic London

To enter one of our Clinical Studies at The Retina Clinic London, please contact info@theretinacliniclondon.com or on 020 4548 5310.

We have several Observational and Interventional Clinical Studies on-going at our clinic.

All our current Clinical Studies are Industry-sponsored and therefore are at no cost to patients. Patients successfully recruited into some of our studies can even be reimbursed for travel and accommodation expenses. However, maximum amounts reimbursed are specific to each Clinical Study and patients are provided with all relevant details in writing.

All our Clinical Studies already have all necessary Ethics Committee approvals, as required on an individual basis.

Patients interested in participating from our Clinical Studies can phone our clinic to request an appointment to assess their suitability for any of the ongoing Clinical Studies. No referral is necessary. However, a clinic letter or an Optician/Optometrist email or letter stating vision in each eye and confirming the diagnosis and can sometimes save the patient an unnecessary screening visit.

Prof. Stanga is our Principal Investigator (PI), Examiner and Surgeon for all our Clinical Studies. Prof. Stanga is supported by his dedicated Retinal Research Team.

Dry Age-Related Macular Degeneration (Dry AMD) is the most common cause of severe loss of central vision and for which there is currently no approved treatment and carries a significant cost to the individual suffering from it as well as to society.

Patients with Geographic Atrophy secondary to Dry-AMD are offered the opportunity to participate in one of the Clinical Studies at The Retina Clinic London.

Our CURRENTLY RECRUITING CLINICAL STUDIES in Dry AMD are as follows:

EXPLORE

EXPLORE: Gene Therapy Surgery with Subretinal Injection

Key inclusion criteria	Key exclusion criteria
Age 55 or older	Have a history, or evidence, of CNV
Snellen Visual Acuity: 6/95 or better	History of intraocular surgery in the study eye within 12 weeks prior to Screening
Geographic Atrophy secondary to AMD	Have received a gene or cell therapy at any time

A randomized Interventional Study comprised of; A single treatment Interventional Clinical Study Arm OR an Observational Clinical Study Arm (placebo). Those randomized to the treatment part of the Clinical Study will receive either a low or high dose. The number of follow up visits depend on which arm of the study you are randomized too.

Patient participation consists of a screening period of up to 8 weeks, and a 48-week study period for a total of 56 weeks. The study eye (treatment or control) will be allocated randomly if both eyes are eligible.

Patient appointments required

Following the Clinical Study Screening (Visit 1) appointment where eligibility is confirmed, the patient will be randomised to either the treatment arm of the Clinical Study or the untreated control. Those randomised within the treatment arm of the Clinical Study will be randomised further into either low or high dose.

If the patient is randomised to the ‘Treatment’ part of the Clinical Study the single surgery will be scheduled within 8 weeks of the screening visit (Visit 2).

After surgery there is a follow-up visit the following day. Additional follow-up visits will follow after week 1 (visit 3), week 5 (visit 4), week 8 (visit 5), week 12 (visit 6), week 36 (visit 8), week 48 (visit 9), week 72 (visit 10) and week 96 (visit 11).

Those randomised to the Untreated Control part of the Clinical Study include: Day 1 (visit 1 Screening), week 12 (visit 6), week 24 (visit 7), week 36 (visit 8), week 48 (visit 9), week 72 (visit 10) and week 96 (visit 11).

Each visit will include a range of Visual Function tests.

We will soon be also recruiting into the following different studies:

One-Off Gene Therapy Intravitreal Injection in patients with GA secondary to Dry AMD
A series of intravitreal injections of a VEGF-C/D inhibitor in comparison with already available comparator drugs in patients with Neovascular AMD
A series of intravitreal injections in subjects with CI-DME previously treated with anti-VEGF treatment who may benefit from a new mechanism of action

Please see Inclusion/Exclusion Criteria:

One-Off Gene Therapy Intravitreal Injection in patients with GA secondary to Dry AMD

Key inclusion criteria	Key exclusion criteria
Age 60 or older	History of or presence of retinal disease other than GA
non-subfoveal GA secondary to AMD	Uncontrolled glaucoma or advanced glaucoma
Snellen Visual Acuity: 6/60 or better	Any previous intraocular or periocular surgery or intraocular laser procedure within 3 months

A series of intravitreal injections of a VEGF-C/D inhibitor in comparison with already available comparator drugs in patients with Neovascular AMD

Key inclusion criteria	Key exclusion criteria
Age 50 or older	Any previous treatment for wet AMD, or previous treatment for CNV due to other causes, in the Study Eye
Active choroidal neovascular (CNV) that is secondary to age-related macular degeneration (AMD)	Clinically significant ocular disorders (other than wet AMD)
Snellen Visual Acuity: between 6/19 and 6/95	Choroidal neovascularization due to causes other than AMD in the Study Eye

A series of intravitreal injections in subjects with CI-DME previously treated with anti-VEGF treatment who may benefit from a new mechanism of action

Key inclusion criteria	Key exclusion criteria
Age 18 or older	Macular oedema due to causes other than DME in the study eye
Type 1 or type 2 diabetes	Uncontrolled glaucoma in the study eye
Snellen Visual Acuity: between 6/12 and 6/95	Untreated diabetes
Received ≥ 5 anti-VEGF injections (any kind) for the treatment of CI-DME	Ocular trauma (including corneoscleral laceration, lens subluxation, cryoretinopexy) in the study eye within 6 months

To enter one of our Clinical Studies at The Retina Clinic London, or for more information, please contact info@theretinacliniclondon.com or on 020 4548 5310.